Rifaximin for the Treatment of Persistent Symptoms in Patients With Celiac Disease
|ClinicalTrials.gov Identifier: NCT01137955|
Recruitment Status : Completed
First Posted : June 7, 2010
Last Update Posted : January 21, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Celiac Disease||Drug: Rifaximin Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Double-blind Randomized Controlled Trial of Rifaximin for Persistent Symptoms in Patients With Celiac Disease|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
Rifaximin 400mg orally three times a day for 10 days total
Other Name: Placebo orally three times a day for 10 days total
|Placebo Comparator: Placebo||
Placebo orally three times a day for 10 days total
Other Name: Rifaximin 400 mg orally three times a day for 10 days total
- To evaluate Gastrointestinal Symptom Rating Scale (GSRS) score improvement after administration of study drug, compared to baseline (week 0) [ Time Frame: 2 and 12 weeks ]Validated seven point questionnaire that assesses gastrointestinal symptoms for five symptom areas, including abdominal pain, reflux, indigestion, diarrhea, and constipation.
- To evaluate Lactulose hydrogen breath test improvement after administration of study drug, compared to baseline (week 0) [ Time Frame: 2 and 12 weeks ]Breath test that measures small intestine bacterial overgrowth.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01137955
|United States, New York|
|Celiac Disease Center at Columbia University|
|New York, New York, United States, 10032|
|Principal Investigator:||Peter HR Green, MD||Columbia University|