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NCT02108821 · ClinicalTrials.gov registry record · Phase 1
Fecal Microbiota Transplantation in Pediatric Patients
A Phase 1 study, sponsored by Children's Mercy Hospital Kansas City.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT02108821: Completed Phase 1 study, sponsored by Children's Mercy Hospital Kansas City.
NCT02108821 is a Phase 1 study that has completed, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02108821, a Phase 1 study, has completed, sponsored by Children's Mercy Hospital Kansas City.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study 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.
Primary Outcome
Adverse events recorded to determine safety of Fecal Microbiome Transplant in the treatment of children with IBD.
Interventions
- BIOLOGICAL Fecal Microbiota Transplantation (FMT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2014-03 |
| Est. Completion | 2016-09-30 |
| Phase | Phase 1 |
What the finished NCT02108821 record still lists
NCT02108821 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Fecal Microbiota Transplantation (FMT) is the first listed.
NCT02108821 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02108821 about?
NCT02108821 is a clinical study titled "Fecal Microbiota Transplantation in Pediatric Patients". 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 residen...
What is the current status of trial NCT02108821?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2014-03. Estimated completion is 2016-09-30.
What interventions are being tested in trial NCT02108821?
The interventions under investigation include: Fecal Microbiota Transplantation (FMT) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02108821?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02108821's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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