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NCT01137955 · ClinicalTrials.gov registry record · NA
Rifaximin for the Treatment of Persistent Symptoms in Patients With Celiac Disease
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT01137955: Completed NA study, sponsored by Columbia University.
NCT01137955 is a NA study that has completed, run by Columbia University. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01137955, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study Summary
Celiac disease is a condition in which the small intestine is damaged by gluten, the storage protein of wheat and similar proteins in barley and rye. The disease can cause different symptoms such as diarrhea, bloating, abdominal pain and weight loss. The majority of patients respond to a gluten-free diet. However some patients (5-30%) have persistent symptoms and are considered to be poor responders to the diet. Bacterial overgrowth in the small intestine accounts for some of the refractory patients. This study seeks to determine if antibiotic therapy with rifaximin relieves the symptoms of patients who are poorly responsive to a gluten-free diet and whether this impacts their breath test results.
Primary Outcome
Validated seven point questionnaire that assesses gastrointestinal symptoms for five symptom areas, including abdominal pain, reflux, indigestion, diarrhea, and constipation. Individual scores are calculated for each symptom area and the mean of the scores is used to derive an overall GSRS score. Scores range from 0-7, with higher scores indicating gastrointestinal discomfort.
Interventions
- DRUG Placebo
- DRUG Rifaximin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2006-10 |
| Est. Completion | 2008-04 |
| Phase | NA |
What the finished NCT01137955 record still lists
NCT01137955 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01137955 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01137955 about?
NCT01137955 is a clinical study titled "Rifaximin for the Treatment of Persistent Symptoms in Patients With Celiac Disease". Celiac disease is a condition in which the small intestine is damaged by gluten, the storage protein of wheat and similar proteins in barley and rye. The disease can cause different symptoms such as diarrhea, bloating, abdominal pain and weight loss. The majority of patients respond to a gluten-free...
What is the current status of trial NCT01137955?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2006-10. Estimated completion is 2008-04.
What interventions are being tested in trial NCT01137955?
The interventions under investigation include: Placebo (DRUG), Rifaximin (DRUG).
Who is sponsoring clinical trial NCT01137955?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01137955's enrollment target sits among peer trials
50 1279th of 2000 higher than 622 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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