Phase 1
N=23
Fecal Microbiota Transplantation in Pediatric Patients
Inflammatory Bowel Diseases (IBD) · Crohn's Disease (CD) · Ulcerative Colitis (UC)
Bottom Line
View on ClinicalTrials.gov: NCT02108821 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Number of Occurrences of Adverse Events at 6 Months According to Adverse Event Term — 11; 5; 5; 3 Events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Fecal Microbiota Transplantation (FMT) (Biological)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Children's Mercy Hospital Kansas City
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Occurrences of Adverse Events at 6 Months According to Adverse Event Term |
11; 5; 5; 3; 2; 2 | — |
| SECONDARY Examine the Efficacy of Fecal Microbiome Transplant in the Treatment of Children With IBD Using the Pediatric Ulcerative Colitis Activity Index (PUCAI) and the Pediatric Crohn Disease Activity Index (PCDAI) Analysis. |
40; 11.6; 11.6; 1.6; 21.6; 0 | — |
Summary
A disturbance in the diversity of gut bacterial composition could be linked to several immune mediated diseases including inflammatory bowel diseases (IBD). IBD can be classified into Crohn's Disease (CD) and Ulcerative Colitis (UC). Both these diseases occur from abnormal immune reaction to resident gut bacteria.The process of fecal microbiota transplantation (FMT) where fecal bacteria from a healthy individual is transferred into a recipient, has recently received attention as an alternative therapy for individuals affected with these life-altering diseases. In this study, the investigators will perform fecal transplantation on the subjects meeting inclusion criteria, to determine the efficacy and safety of this therapy in subjects with IBD (CD and UC) who are not responding to first line therapy, and are in a flare.
Eligibility Criteria
STUDY SUBJECT INCLUSION CRITERIA:
Current IBD patients who have:
- UC patients with a flare due to failure of current therapy and have to undergo esophagogastroduodenoscopy (EGD) and colonoscopy for restaging the disease and escalation of therapy.
- CD patients with ileo colonic or colonic disease who require an EGD and colonoscopy for disease assessment due to a flare or poor control.
- The ability to safely undergo colonoscopy (physical status classification used by the American Society of Anesthesiologists).
- PUCAI score less than sixty five.
- PCDAI score less than forty.
STUDY SUBJECTS EXCLUSION CRITERIA:
- Patients with Crohn's disease: complications like an abscess, phlegmon, stricture, small bowel obstruction, perforation, internal or external fistulization or infection as causes for flare up before being deemed eligible for recruitment to the study. We will check for these complications if a recent study has not been done.
- Severe immunosuppression: Biologicals with concomitant steroids (>30 mg/day).
- Central Line.
- Pressor or ventilatory support.
- On antibiotics.
- Patients with Crohn's disease found to have complications like an abscess, phlegmon, stricture, small bowel obstruction, perforation, internal or external fistulization or infection.
- Not willing to consent or follow guidelines throughout research trial.
- Screening labs in either donor or recipient reveal problems with performing fecal microbiome transplantation because inclusion requirements are no longer met.
- Physician discretion.
- Participant request.
DONOR EXCLUSION CRITERIA:
- A history of antibiotic treatment during the 3 months preceding donation.
- A history of intrinsic gastrointestinal illnesses.
- A history of autoimmune or atopic illness or modulating therapy.
- A history of chronic pain syndromes, or neurologic or neurodevelopmental disorders.
- Metabolic syndrome or malnutrition or obesity.
- A history of exposure to infectious agents.
- Diarrhea or other symptoms of an intestinal infection within two weeks prior to, or on the day of, stool donation.
- A history of malignant illnesses or ongoing oncologic therapy.
- Weight less than 15 kgs.
Data sourced from ClinicalTrials.gov (NCT02108821). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.