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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 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 6 participants.
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.
Interventions
- BIOLOGICAL Fecal Microbiota Transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2014-02 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01947101
The ClinicalTrials.gov registry entry for NCT01947101 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fecal Microbiota Transplant is the first listed.
NCT01947101 reports 0 study locations.
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.
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