Journal of Pediatric Nursing (2014) xx, xxx–xxx

What Nurses Need to Know About Fecal Microbiota Transplantation: Education, Assessment, and Care for Children and Young Adults1,2 Bennett P. Samuel MHA, BSN, RN ⁎, Teri L. Crumb BSN, RN, CCRC, Mary M. Duba BSN, RN 3 Clinical Research Nurse, Office of Clinical Research Operations, Offices of Research Administration, Helen DeVos Children's Hospital of Spectrum Health, Grand Rapids, MI Received 19 December 2013; revised 30 January 2014; accepted 30 January 2014

Key words: Fecal microbiota transplantation; Clostridium difficile; Ulcerative colitis; Patient education; Nursing assessment; Nursing care; Clinical research nurse

Fecal microbiota transplantation (FMT) is an emerging experimental therapy for treatment of recurrent Clostridium difficile infection. In the future, FMT has the potential to be a treatment modality in other diseases that involve gut dysbiosis. As use of FMT is likely to expand, pediatric nurses need a clear understanding of FMT to provide appropriate education, assessment, and care for these patients. Pediatric research and clinical nurses are a resource to help children and parents understand the procedure. Important topics include donor screening, patient assessment before, during, and after treatment; routes of administration and positioning; preparation for discharge and followup evaluation. © 2014 Elsevier Inc. All rights reserved.

FECAL MICROBIOTA TRANSPLANTATION (FMT), also known as stool transplantation, is the infusion of human stool, obtained from a healthy donor, into the gastrointestinal (GI) tract of a diseased patient. Hypothesized to normalize the gut microbiota of the recipient, FMT helps to alleviate disease symptoms by modulating dysbiosis (Khoruts, Dicksved, Jansson, & Sadowsky, 2010; van Nood et al., 2013). Here dysbiosis refers to the microbial imbalance in the intestinal tract. The 17th century Italian anatomist, Fabricius Aquapendente, first described stool transplantation in animals (Borody, Warren, Leis, Surace, Ashman, & Siarakas, 2004). This practice continues to be performed

1

This article has a clinical focus. Special thanks to Karen J. Vander Laan PhD, MSN, RN, Bonnie Whaite MSN, RN, and Danny L. Balfour PhD for editorial support and guidance, and Sandy Kommit MILS, BA, RN for literature acquisition. ⁎ Corresponding author: Bennett P. Samuel, MHA, BSN, RN. E-mail address: [email protected]. 3 Mary M. Duba is now at System Quality Department, Spectrum Health, Grand Rapids, MI. 2

0882-5963/$ – see front matter © 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.pedn.2014.01.013

today, for example, “…veterinarians perform fecal transplantation to treat horses with diarrhea by infusing stool from healthy horses into the rectum of the sick animals, and they administer rumen fluid [transfaunation] to cows and alpacas to treat a variety of conditions” (Hanauer, 2012, p. 191). Since the 1950s, FMT has been used sporadically in human patients with pseudomembranous enterocolitis and Clostridium difficile infection (CDI) as it has been shown to alter the gut microbiota of the recipient (Eiseman, Silen, Bascom, & Kauvar, 1958; Khoruts et al., 2010; van Nood et al., 2013). A systematic review of 27 clinical trials and case reports between 1957 and 2009 found that 92% of over 300 patients with recurrent CDI experienced symptom resolution after treatment with FMT (Gough, Shaikh, & Manges, 2011). Similarly, a literature review of 11 clinical trials and case reports between 2010 and 2011 shows a 92% success rate of FMT in 182 patients with fulminant or refractory CDI (Karadsheh & Sule, 2013). Various routes of instillation for FMT are described in these studies and case reports. The most common methods include retention enema, colonoscopy, and administration via nasojejunal (NJ) tube.

2 In 1989, Bennet and Brinkman were the first to report the successful use of FMT in a patient with ulcerative colitis (UC), an inflammatory bowel disease (IBD; Bennet & Brinkman, 1989). A similar case series was reported in six adult patients (Borody, Warren, Leis, Surace, & Ashman, 2003). Both these case reports show an improvement in UC symptoms and a reversal of the disease process in patients treated with FMT. Many patients were also able to stop taking medications for their UC. More recently, a small phase I prospective, non-randomized FMT clinical trial was conducted to treat ten children and young adults with UC (Kunde et al., 2013). Clinical results found that 78% of the subjects demonstrated improvement in UC symptoms within 1 week of the treatments and 67% maintained clinical response at 1 month after the final FMT treatment day. Fecal microbiota transplantation is considered to be an investigational biologic drug (Public Health Service Act of, 1999; Federal Food, Drug, and Cosmetic Act, 1980). Currently, FMT can only be offered in clinical settings to patients with recurrent CDI if an adequate informed consent is obtained from the recipient indicating the experimental nature of the therapy. The use of FMT in other conditions is limited to clinical trials (United States Food and Drug Administration, 2013). Due to the therapeutic potential of FMT, although still poorly understood, researchers across the globe will further explore the biological plausibility, safety, and clinical responses in children and young adults with CDI, IBD (UC and Crohn's disease), anorexia nervosa, constipation, diabetes mellitus, eosinophilic disorders of the GI tract, food allergies, irritable bowel syndrome (IBS), obesity, neurodegenerative and neurodevelopment disorders, and systemic autoimmunity disorders (Borody & Khoruts, 2012; Rogers & Bruce, 2013; Borody, Paramsothy, & Agrawal, 2013). Thus far, FMT has been shown to be safe, effective, and an inexpensive treatment with very few side effects (Bakken et al., 2011; Karadsheh & Sule, 2013). As a result of the positive impact of FMT in patients with recurrent CDI, it is likely to become a regularly used treatment modality in outpatient and acute care settings for children and young adults with disease processes that involve gut dysbiosis. Pediatric nurses have limited available information about providing adequate education, appropriate assessment, and quality care for patients receiving FMT. The purpose of this article is to review the FMT procedure in pediatric patients with CDI and UC and discuss its implications for nursing practice in the clinical and research settings.

Clinical Research Nurses – A Critical Resource As a result of the Food and Drug Administration (FDA) federal regulations, pediatric clinical research nurses have an essential role in working with children and young adults receiving FMT and collaborating with clinical teams. The main roles and responsibilities of the clinical research nurse include completing regulatory documents, creating a budget and assessing site costs, preparing institutional review board

B.P. Samuel et al. (IRB) submissions, developing an informed consent form, and building tools for data collection and education of patients and families. Clinical research nurses facilitate the identification and screening of potential research subjects, coordinate and schedule visit appointments, perform nursing assessments, educate patients and families and collect data and/or specimens according to the study protocol (Fedor, Cola, & Pierre, 2006). Initially, FMT may sound unappealing to many children and their families. Preparation of the pediatric research participant and their families is a critical step in the screening phase. For other children and young adults, due to the debilitating symptoms of recurrent CDI and UC, families are desperate for alternative treatment options and may consider performing FMT at home. There may be an increased risk for the transmission of infection in home treatments due to improper or lack of donor screening. The lack of medical supervision may also result in other unknown risks. Clinical research nurses play a key role in informing research participants and parents/guardians about the investigational nature of FMT and any potential risks. Education of the research participants and family members may be provided through phone, email and IRBapproved study teaching tools. Detailed information about FMT, including all aspects of the process are required to be made available in writing to the research participants, their parents/guardians, and donors. These aspects include donor selection, donor screening and testing, donor stool collection process, participant screening, method and route of administration, side effects, how to report adverse events, intraprocedural and post treatment considerations, compensation and payment for treatment, and other treatment options. Typically, the IRB-approved informed consent incorporates this information and includes the contact information of the study personnel in case the research participant has a question or wants to withdraw from the study. The clinical research nurse facilitates the authorization of parent/guardian permission for children less than 18 years of age to participate in a research study according to the United States Department of Health and Human Services (2009). Clinical research nurses have an ethical responsibility to evaluate the education provided to the study participants and assess their abilities to make a decision, demonstrate a factual understanding of the information, and appreciate the nature of their decision to participate and its consequences compared to other treatment options (Strauss, 2013). All capable research participants greater than or equal to 18 years of age are required to sign their own informed consent. A signed copy must be given to the participant or their families, as applicable, for their records. It is also important to include children in decisions about research. Often children are excluded from these discussions with the excuse that they lack the capacity to understand research and/or clinical procedures. However, “children have the right to decide for themselves if they want to participate, and researchers have a responsibility to develop processes to

Nurses Need to Know About Fecal Microbiota Transplantation ensure a child understands the assent process” (Crumb, 2012, p. 24). Child assent is a requirement of United States FDA regulated research. Thus, all children between 7–17 years of age should be given information about FMT in language adapted to their developmental level. Information given to children should include the study procedures and side effects. The children should then be asked if they wish to participate in the research study and assented according to the United States Department of Health and Human Services (2009).

FMT in the Clinical Setting Acute care and ambulatory care nursing staff will also provide information about FMT to patients, their parents/ Table 1

3 guardians, and donors in the clinical setting. Although FDA approval is recommended for clinical treatment of recurrent CDI using FMT, it is not required (United States Food and Drug Administration, 2013). Instead, the hospital risk and compliance or legal department may be involved in reviewing and approving the necessary documents for FMT treatment such as an informed consent. Resources developed by the clinical research nurses may be modified for use in the clinical setting. A comparison of FMT in the clinical and research settings is provided in Table 1. Preparation for FMT is an important aspect for successful treatment, with education given about pre-treatment prescriptions, over-the-counter medications, and bowel preparation. Many children and young adults may also be uncomfortable and anxious about the psychological idea of

Comparison of FMT in clinical and research settings.

FDA approved protocol Education

FMT in clinical setting Suggested FMT procedures in all settings (recurrent CDI)

FMT in research setting (recurrent CDI, UC, or other conditions)

Not required, but recommended Report adverse symptoms

Required Participant screening

Report adverse events

Donor selection

Other clinical treatment options Compensation

Donor screening and testing Method and route of administration Psychosocial preparation Post-treatment considerations and discharge planning Treatment cost/payment Informed consent

Hospital-approved consent/assent

Pretreatment

Nursing baseline assessment of symptoms Psychosocial assessment for anxiety Bowel preparation* Sigmoidoscopy/Colonoscopy evaluation* Baseline Mayo score* Antibiotic therapy* Proton pump inhibitor* NG, ND, NJ, and endoscopy: sitting at 45–90 degree angle

Route of administration and patient positioning

During FMT treatment Monitor for adverse symptoms Post FMT treatment

IRB-approved consent/ assent

Clinic visits*

Sigmoidoscopy, colonoscopy, and retention enema: left lateral decubitus position Nursing assessment Psychosocial assessment and support Nursing assessment of clinical response Psychosocial assessment and support

Follow-up phone call Education about nutrition and medications Assessment for clinical remission with possible sigmoidoscopy or colonoscopy,* Mayo score,* laboratory tests* Note. *Based on patient condition, physician preference (clinical setting) and protocol requirements (research setting).

Monitor for adverse events Clinic visits* Patient completes symptom diary post treatment*

4

B.P. Samuel et al. Table 2 tests. Serum

Stool

Donor screening laboratory blood serum and stool Hepatitis A immunoglobulin M (IgM) Hepatitis B surface antigen (Ag) Hepatitis C antibody (Ab) HIV I & II enzyme linked immunosorbent assay (ELISA) Syphilis rapid plasma reagin (RPR) Clostridium difficile toxin B polymerase chain reaction (PCR) Culture for Campylobacter, Escherichia coli, Salmonella, Shigella, and Yersinia Ova and parasite (O&P) exam

Note. Adapted from “Guidance on preparing an investigational new drug application for fecal microbiota transplantation studies,” by Kelly, Kunde, & Khoruts, 2014, Clinical Gastroenterology and Hepatology, 12(2), p.285.

having someone else's stool placed into their own body. Nurses play a significant role in educating about FMT, utilizing child life personnel to help reduce anxiety. This empowers children and young adults, and their family members with relevant information at each step of the FMT process to help them make an informed decision. A common concern raised by parents/guardians is the potential risk of transmission of infection from FMT. Reassurance can be given through explanation of the extensive screening and testing procedures that a donor is required to complete prior to patient treatment. Table 2 provides the recommended donor laboratory screening blood serum and stool tests. Additional laboratory screening tests may be added, and others may be removed based on research findings and the recommendations of the FDA (Kelly et al., 2014). To date, there have been no reported cases of transmission of infection in over 370 patients treated with FMT (Bakken et al., 2011; Borody & Khoruts, 2012; Karadsheh & Sule, 2013). However, the informed consent for clinical treatment should disclose that there may be unknown risks or complications for the recipient.

FMT Pretreatment Considerations Although rigorously screened anonymous volunteer donors can be used, which may reduce the natural antipathy towards FMT, some patients and their families may still prefer to select a known volunteer donor (Hamilton, Weingarden, Sadowsky, & Khoruts, 2012). The inclusion and exclusion criteria are based on guidelines provided by the FDA, and the American Gastroenterological Association (AGA). The American Association of Blood Banks' Donor History Questionnaire (DHQ) is a useful guide for donor screening that includes the recommendations of the FDA and AGA. The DHQ includes questions about health and wellness, medical history, antibiotic use, illegal drug use, lifestyle and sexual history (Bakken et al., 2011; Kunde et

al., 2013; Kelly et al., 2014). The questionnaire should be modified to include additional questions to rule out GI comorbidities and factors that may affect the composition of the intestinal microbiota, such as a history of GI conditions or recent medications (Bakken et al., 2011). The donor informed consent must provide information about all the procedures involved in becoming a donor. It should disclose the highly sensitive and personal questions included in the DHQ. The measures taken to maintain confidentiality of the donor's protected health information must be described in detail as well as how the donor will be informed about any relevant information such as a positive screening test result (Kelly et al., 2014).

Pretreatment Nursing Assessment It is important for nurses to perform a thorough nursing assessment prior to FMT treatment to learn about the child or young adult's baseline disease activity status. Some patients may have mild persistent disease symptoms that may confound the symptoms experienced during the FMT treatment. The symptoms of CDI and UC are similar and include abdominal pain, cramping, frequency, hyperactive bowel sounds, loose liquid stools, and urgency (Ackley & Ladwig, 2013). Key nursing diagnoses from the assessment of patients with CDI and UC may include • acute pain related to abdominal cramping and anal irritation; • deficient fluid volume, impaired skin integrity, and/or impaired social interaction related to frequent and loose stools; • imbalanced nutrition: less than body requirements related to anorexia or decreased absorption of nutrients from the GI tract; • ineffective coping related to repeated acute episodes of the disease symptoms (Ackley & Ladwig, 2013). In addition, nocturnal stools may lead to sleep deprivation, daytime drowsiness, fatigue, irritability and lethargy (Ackley & Ladwig, 2013). Patients with UC may also have varying amounts of blood in their stool. Female patients with UC may report worsening symptoms during their menstrual cycle. Kane, Sable, and Hanauer (1998) suggest that the physiological and clinical effects during the menstrual cycle should be taken into consideration when assessing disease activity. Documentation of the baseline assessment is valuable to both patients and pediatric nurses in assessing and addressing the intra-procedural and post-treatment symptoms. A diagnosis of CDI is typically confirmed by laboratory testing for C. difficile toxin B by polymerase chain reaction (PCR). Endoscopic evaluation may be done in both CDI and UC patients to evaluate the extent of the disease. For UC patients, the Pediatric Ulcerative Colitis Activity Index

Nurses Need to Know About Fecal Microbiota Transplantation Table 3

Pediatric Ulcerative Colitis Activity Index.

Item 1. Abdominal pain No pain Pain can be ignored Pain cannot be ignored 2. Rectal bleeding None Small amount, only, in b 50% of stools Small amount with most stools Large amount (N 50% of the stool content) 3. Stool consistency of most stools Formed Partially formed Completely unformed 4. Number of stools per 24 h 0–2 3–5 6–8 N8 5. Nocturnal stools (any episode causing wakening) No Yes 6. Activity level No limitation of activity Occasional limitation of activity Severe restricted activity

Points 0 5 10

5 differences may be specific to the child or young adult's needs and condition, provider preference and/or protocol requirements (Aas, Gessert, & Bakken, 2003; Hamilton et al., 2012; Kelly et al., 2014).

FMT Procedure 0 10 20 30 0 5 10 0 5 10 15 0 10 0 5 10

Note. Sum of PUCAI (0–85). Reprinted with permission from “Development, validation, and evaluation of a pediatric ulcerative colitis activity index: A prospective multicenter study,” by D. Turner et al., 2007, Gastroenterology, 133(2), p.431.

(PUCAI) may be used for baseline assessment (Table 3). The PUCAI is a noninvasive, highly reliable and validated index that can be used to accurately differentiate the disease activity states. Acute care and ambulatory nursing staff may be able to utilize this index during nursing assessment of pediatric patients with UC to assess disease activity change over time. A score of less than 10 means that a patient is in remission; a patient with mild disease has a score between 10 and 34; 35 to 64 is defined as moderate disease and 65 to 85 as severe disease. Scores are based on symptoms experienced by the patient over an average of the last 2 days as reported on the PUCAI. Symptoms include abdominal pain, rectal bleeding, stool consistency, number of stools, and limitation(s) to daily activity (Turner et al., 2007). Prior to starting FMT treatment, all female patients are required to have a negative pregnancy urine test due to unknown risks to the fetus. The risks to breast-fed babies are also unforeseeable, and nursing mothers are not permitted to receive FMT treatment (Kelly et al., 2014). Common pretreatment medication orders may include daily doses of antibiotic therapy, a polyethylene glycol bowel preparation the night before the first FMT treatment day for lower GI route of administration (e.g. colonoscopy), or proton pump inhibitor on the morning of the treatment day. Currently, there is no clinically standardized order set, and any

Treatment may consist of a single dose of FMT or multiple doses depending on the condition of the child/young adult, the patient's response during the treatment and the effectiveness of the treatment (Kelly et al., 2014). Some studies have successfully used frozen stool preparation thawed prior to the administration of FMT (Hamilton et al., 2012). Other studies have used fresh stool produced within 6 hours of FMT treatment (Kunde et al., 2013). The fresh stool sample is prepared by blending it with warmed (37 °C) sterile normal saline using a conventional household blender dedicated to this purpose. The fecal product is then filtered using two pieces of gauze or stainless steel strainers to remove large sediments, and the filtrate is divided into aliquots (Hamilton et al., 2012; Kunde et al., 2013). For the patient's comfort, the FMT preparation is placed in a water bath (37 °C) before it is infused into a recipient's colon, diminishing the occurrence of abdominal cramping. Retention enema is the most common route of administration for FMT. Other routes may include colonoscopy, sigmoidoscopy, nasogastric (NG), nasoduodenal (ND) and NJ tubes (Bakken et al., 2011). When retention enema is used as the route of administration, subjects typically receive two ounces every 15 minutes for a total of 6 to 8 ounces over 1 hour. The goal of each treatment is for the patient to retain the content of the FMT preparation for as long as possible, but preferably for at least 1 hour. The subjects are monitored for 30 minutes following the final two ounces of the FMT treatment. Vital signs, comfort, pain and adverse symptoms or events should be included in the nursing assessment of these patients (Kunde et al., 2013; Kelly et al., 2014).

Route of Administration and Patient Positioning The route of administration and patient positioning are dependent on the child or young adult's condition, physician preferences and/or protocol requirements.

Lower GI Tract Patients are positioned in a left lateral decubitus position for a retention enema, sigmoidoscopy or colonoscopy. Nurses will need to assess the need for sedation and/or pain management. Throughout the administration of FMT via retention enema, patients are periodically asked to rotate

6 180 degrees to a right lateral position and back to the left lateral position (Kunde et al., 2013). Position changes are thought to promote movement of the FMT preparation through the entire colon, from descending colon to transverse colon to ascending colon. Sigmoidoscopy allows for the infusion of the FMT preparation into a more proximal segment of the colon than an enema and may be beneficial in patients who have difficulty retaining the material. Similarly, FMT via colonoscopy allows for the infusion of the FMT preparation into the entire colon. A complete endoscopic examination of the colon can also be done and determine comorbid conditions which may affect the patient's response to the therapy. An advantage to using this endoscopic method of administration is instillation of the FMT preparation in highly affected areas of the intestinal tract. Typically, about 0.7 ounces of the FMT preparation is instilled via the biopsy channel of the colonoscope every 5 to 10 cm as the scope is withdrawn for a total of 8 to 15 ounces (Agito, Atreja, & Rizk, 2013). Any kind of rectal treatment can be physically uncomfortable. There is also the element of personal dignity being compromised. Nurses can help improve the child or young adult's dignity during the FMT treatment by providing privacy, keeping the body covered except for the rectal area, being calm and matter-of-fact about the procedures and explaining each step of the process to the patient. Child life personnel may also help to divert the pediatric patient's attention away from the uncomfortable procedures by providing activity options such as watching a movie or other activities that can be done while lying down. Age, gender, and developmental level may influence the child or young adult's decision to have a parent present in the room during the FMT treatment. Nurses should ask specific questions to determine the patient's choice and help facilitate appropriate needs prior to the start of the FMT administration. The rectal infusion of FMT may cause the patient to experience a sudden urgency for bowel elimination. By providing a bedside commode, nurses can prevent children and young adults from having embarrassing incontinence. Easy access to bathroom tissues, wipes, air freshener and any other supplies are also important in decreasing their anxiety about FMT. By demonstrating sensitivity to the child or young adult's needs, pediatric nurses can protect the dignity of their patients and ensure that they feel comfortable throughout the FMT treatment.

Upper GI Tract The mechanism of administration for FMT through the upper GI tract includes NG, ND, NJ, and endoscopy. Patients will need to sit upright at a 45 to 90 degree angle to reduce the risk of regurgitation and aspiration. The insertion of the nasal tubes and/or endoscopic procedures may cause pain and discomfort. Sedation may be required to be administered by the nurse or sedation team. Nurses

B.P. Samuel et al. must communicate with the physician and/or sedation team to provide adequate comfort and pain management for the patient as well as appropriate nursing assessment and care. Nurses play an important role in informing the child or young adult about each step, helping to position, and reducing their anxiety. Again, child life personnel may be beneficial in calming pediatric patients during the FMT procedure.

During FMT Treatment Human stool is treated as a level II biohazard (United States Department of Health and Human Services, 2013). Nurses have a critical role in infection control during FMT to prevent the transmission of infection especially in the case of CDI. Hand hygiene must be performed upon entering the room. More importantly, before leaving the patient room, hand hygiene must be performed with soap and water followed by an alcohol-based sanitizer. Gloves and gowns must be worn at all times by healthcare providers and visitors entering the room. Environmental cleaning of surfaces should be done using chlorine-containing and/or sporicidalcontaining disinfectant wipes as C. difficile spores can survive on inanimate objects for several months to years (Cohen et al., 2010). In addition, everyone in the treatment room should wear eye protection during all cases of FMT administration to reduce the risk of exposure to pathogens from an accidental splash. Each child or young adult should be continually assessed for comfort and ability to tolerate the volume at each increment or aliquot. During the instillation of FMT via retention enema, some patients may be unable to tolerate the initial enema due to urgency leading to immediate leaking and may have to be withdrawn from the treatment. In the study by Kunde et al. (2013), nine subjects were able to tolerate a volume range of 2.5 to 8 ounces. The range for the retention time was 3 to 24 hours with a mean retention time of 10 hours. Younger and older subjects equally tolerated the volume of the enemas with similar retention times (M. Plets, personal communication, October 21, 2013). Patient assessment should include vital signs, pain level, and any other concerns, such as anxiety or positioning. The adverse symptoms may be adequately addressed by comparing the pre-procedure to the intra-procedural and post-treatment assessment and symptoms. Intra-procedural and post-treatment symptoms reported by children and young adults are similar to the ones experienced by patients resulting from disease processes of CDI and UC. Common treatment-related symptoms include bloating/flatulence, abdominal pain/cramping, diarrhea, blood in stool, and fatigue. Fever, GI hemorrhage, headache, nausea, vomiting, constipation, and signs of an irritable colon are other reported adverse symptoms. Antipyretics and antihistamines prior to the treatment may help to control patient immune response symptoms such as fever. Except for

Nurses Need to Know About Fecal Microbiota Transplantation fever, none of the adverse events has been classified as directly related to FMT (Gough et al., 2011; Kunde et al., 2013). In upper GI route of administration, nurses should monitor for signs of increased intra-abdominal pressure, which puts the patient at higher risk for vomiting and aspiration. The procedural insertion of any tubes (NG, ND, and NJ) and scopes (upper endoscopy, sigmoidoscopy, and colonoscopy) also increases the risk for GI tract perforation in patients during FMT. Perforation of the GI tract can have serious consequences such as peritonitis or sepsis. Therefore, nursing assessment during and after FMT is important to assess for and address any adverse events that may occur.

Post FMT Treatment Children and young adults treated with FMT in the outpatient setting are typically monitored for 30 minutes post-treatment and are able to go home. Some physicians may prescribe anti-motility drugs to help retain the FMT preparation (Kunde et al., 2013; Kelly et al., 2014). Patients may resume a normal diet after receiving FMT through the lower GI route of administration, but bed rest is recommended for at least 2 hours to decrease GI motility and increase the retention time of the FMT preparation. Afterwards, patients are permitted to resume all customary physical activities. Patients who receive the treatment through the upper GI route of administration are allowed to resume a normal diet and physical activities immediately after discharge (Aas et al., 2003). Children and young adults need education of the various adverse events and how to immediately report them to their parents and healthcare provider. As in any clinical or research setting, patients and their families are informed of any recommended changes to their treatment. It is important for patients to follow up with their healthcare team before stopping any of their medications after FMT. Discharge instructions should include information about resumption of normal diet and physical activity. A follow-up phone call is recommended to assess the child or young adult's condition and address any questions or concerns. Patients and parents/ guardians should also be informed of the need for follow-up clinic visits, lab tests, and possibly a colonoscopy to assess clinical remission. Finally, nurses have an important role in preparing and educating patients for long-term self-assessment and maintenance. Resolution of symptoms without relapse within 8 weeks of FMT treatment is considered a successful treatment of CDI. However, laboratory testing of C. difficile toxin B by PCR is not recommended as patients can be colonized without developing the disease (Cohen et al., 2010; Bakken et al., 2011). In UC patients, clinical response may be measured using the PUCAI assessment tool. Comparison of pretreatment symptoms and PUCAI score

7 can be used to measure clinical response. In some cases, an endoscopic examination may be recommended to visualize the health of the GI tract and assess clinical remission from the disease.

Conclusion The recent surge in research and scientific publications related to FMT shows that it is now gaining acceptance as a valuable treatment option for children and young adults with recurrent CDI. Further research will be needed to explore the mechanism of action of FMT and its safety and efficacy in other disease conditions. Understanding the science behind the treatment will help pediatric nurses to effectively educate patients and their families. It is the role of the nurse to assist children and young adults and their families to overcome the initial natural antipathy towards FMT by providing the patient with adequate information. Expert assessment is required of nurses to deliver quality patient-centered care. Pediatric nurses must also protect the child or young adult's dignity and privacy through individualized care based on developmental level. By coordinating care with appropriate team members, nurses can pave the way for a great patient experience despite an uncomfortable treatment, reduce anxiety, and provide access to a unique treatment for their debilitating disease. A clear understanding of FMT is beneficial for pediatric nurses to provide adequate education, assessment and care for these children and young adults in the research and clinical settings.

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What nurses need to know about fecal microbiota transplantation: education, assessment, and care for children and young adults.

Fecal microbiota transplantation (FMT) is an emerging experimental therapy for treatment of recurrent Clostridium difficile infection. In the future, ...
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