NCT01137955

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
DRUG	Rifaximin	Rifaximin 400mg orally three times a day for 10 days total
DRUG	Placebo	Placebo orally three times a day for 10 days total

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2010-06-07
• Last updated: 2022-06-29
• Results posted: 2022-06-29

Locations

1 site across 1 country: United States