Conditions: Celiac Disease
Keywords: Gastrointestinal Symptom Rating Scale (GSRS) Poorly responsive Refractory Small intestine bacterial overgrowth Breath test
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 50
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Antibiotic ,Rifaximin 400mg, given 3 times a day for 10 days. arm 2: Placebo pills given 3 times a day for 10 days.

Interventions: intervention 1: Rifaximin intervention 2: Placebo
Intervention descriptions: intervention 1: Rifaximin 400mg orally three times a day for 10 days total intervention 2: Placebo orally three times a day for 10 days total

Protocol document: