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NCT01947101 · ClinicalTrials.gov registry record · Phase 1
Fecal Microbiota Transplantation (FMT) for Treatment of Ulcerative Colitis in Children
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01947101: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT01947101 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01947101, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Patients diagnosed with ulcerative colitis (UC), a specific type of inflammatory bowel disease, will be invited to take part in this study. The investigators do not know what causes UC. However, the microbes (such as bacteria and viruses), which normally live in our intestines are thought to play an important role in the development of UC. There are many treatment options for UC such as steroids,and other medications that decrease inflammation. However, none of these can cure the disease. This study aims to treat pediatric UC in an alternative fashion by changing the microbes in the gut by giving the participant's stool specimens from healthy adult individuals. There is some evidence from a few cases of adult UC that this therapy may cure the disease or at least provide long lasting suppression (remission) of the symptoms. The investigators would like to test this therapeutic intervention in children with UC. The purpose of this study is to (1) examine the microbiome of stool and colon (2) and to determine whether healthy-donated stool enemas can treat pediatric ulcerative colitis. (3) The investigators will also study the effects of the treatment on colonic gene expression.
Primary Outcome
To determine the safety and associated toxicities of serial FMTs in pediatric UC following withdrawal from standard therapy.
Interventions
- BIOLOGICAL Fecal Microbiota Transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2014-02 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
What the finished NCT01947101 record still lists
NCT01947101 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Fecal Microbiota Transplant is the first listed.
NCT01947101 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01947101 about?
NCT01947101 is a clinical study titled "Fecal Microbiota Transplantation (FMT) for Treatment of Ulcerative Colitis in Children". Patients diagnosed with ulcerative colitis (UC), a specific type of inflammatory bowel disease, will be invited to take part in this study. The investigators do not know what causes UC. However, the microbes (such as bacteria and viruses), which normally live in our intestines are thought to play an...
What is the current status of trial NCT01947101?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2014-02. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01947101?
The interventions under investigation include: Fecal Microbiota Transplant (BIOLOGICAL).
Who is sponsoring clinical trial NCT01947101?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01947101's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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