drugset / Trial / NCT01137955

Rifaximin for the Treatment of Persistent Symptoms in Patients With Celiac Disease

NCT01137955 ↗

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2006-10
Primary completion
2008-04
Completion
2008-04

Outcome

Missed primary endpoint

paper GSRS scores were unaffected by treatment with rifaximin, regardless of baseline breath tests. PMID 21647654 ↗

paper Rifaximin does not improve patients' reporting of gastrointestinal symptoms and hydrogen breath tests do not reliably identify who will respond to antibiotic therapy. PMID 21647654 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rifaximin Other / unclassified 400 mg Oral

Indications