CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Rifaximin +1 moredrug
Likely dose
Rifaximin 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01137955
NCT01137955N/ACompleted

Double-blind Randomized Controlled Trial of Rifaximin for Persistent Symptoms in Patients With Celiac Disease

Columbia University·interventional·Posted Jun 7, 2010·Updated Jun 29, 2022

In Brief

A clinical study evaluating Rifaximin and Placebo for Celiac Disease. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCeliac Disease
CountriesUnited States

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 7, 2010
Enrollment StartOct 1, 2006
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.1 years ago

Interventions

Rifaximindrug

Rifaximin 400mg orally three times a day for 10 days total

Placebodrug

Placebo orally three times a day for 10 days total