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 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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Double-blind Randomized Controlled Trial of Rifaximin for Persistent Symptoms in Patients With Celiac Disease|
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Breath test that measures small intestine bacterial overgrowth.
|Study Start Date:||October 2006|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
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
A symptom questionnaire will be administered at study initiation, 2 weeks and 12 weeks. Patients will undergo a breath test which involves drinking a sugar (lactulose) solution and breathing into a machine. This technique will identify the presence of bacteria in the small intestine. They will be randomly selected to receive either an antibiotic (rifaximin) or placebo three times a day for 10 days to treat their bacterial overgrowth.
Please refer to this study by its ClinicalTrials.gov identifier: 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|