Rifaximin for the Treatment of Persistent Symptoms in Patients With Celiac Disease - Full Text View

Purpose

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	Intervention
Celiac Disease	Drug: Rifaximin Drug: Placebo

Study Type:	Interventional
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

Resource links provided by NLM:

Genetics Home Reference related topics: celiac disease

MedlinePlus related topics: Celiac Disease

Drug Information available for: Rifaximin

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Enrollment:	41
Study Start Date:	October 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Rifaximin Antibiotic	Drug: Rifaximin 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	Drug: 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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients age 18 or older
Biopsy proven celiac disease
Persistent symptoms of diarrhea, gas, bloating and/or cramping despite a gluten free diet for at least 1 month
Women that are not pregnant or lactating can be included. All women must have a documented negative pregnancy test at the initiation of the study. Women who become pregnant during the study will be asked to discontinue the study drug and will be followed up until the outcome of pregnancy is known. Women of child bearing potential must be practicing an effective method of birth control (eg: prescription oral contraceptive, contraceptive injections, intra-uterine device, double barrier method, contraceptive patch, male sterilization) before entry and throughout the treatment period.

Exclusion Criteria:

antibiotic use for any indication within preceding one month
use of bismuth compounds within preceding month
concomitant use of pancreatic supplements
concomitant use of antispasmodics
concomitant use of immunomodulators such as corticosteroids, budesonide, alkylating agents and antimetabolites.
concomitant use of probiotics
concomitant use of prokinetic agents
concomitant use of 5HT3 antagonists, 5HT4 agonists
concomitant use of antimotility agents (e.g loperamide)
concomitant use of antidiarrheal agents
diagnosed microscopic colitis or inflammatory bowel disease
other causes of malabsorption: pancreatic insufficiency, giardiasis and enteropathy associated with T cell lymphoma.
other diseases: renal or hepatic insufficiency.
pregnant patients and lactating females. In addition women of child bearing age will be excluded if they are not using one of the methods of contraception like oral contraceptives, IUD and double barrier methods.
patients with tuberculosis or a positive PPD test and infection with other mycobaterial diseases.
allergy and/or potential emergence of drug resistance to rifampicin and rafamycin compounds.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137955

Locations

United States, New York
Celiac Disease Center at Columbia University
New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Salix Pharmaceuticals

Investigators

Principal Investigator:

Peter HR Green, MD

Columbia University

More Information

Additional Information:

Information on Celiac Disease from the NIH This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Peter HR Green, Principal Investigator, Columbia University Medical Center
ClinicalTrials.gov Identifier:	NCT01137955 History of Changes
Other Study ID Numbers:	AAAB6531(Y3M00), IRB-AAAB6531(Y3M00)
Study First Received:	June 3, 2010
Last Updated:	January 19, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Columbia University:

Gastrointestinal Symptom Rating Scale (GSRS)
Poorly responsive
Refractory
Small intestine bacterial overgrowth
Breath test

Additional relevant MeSH terms:

Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

Rifaximin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 19, 2013