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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01137955
Recruitment Status : Completed
First Posted : June 7, 2010
Last Update Posted : January 21, 2011
Valeant Pharmaceuticals International, Inc.
Information provided by:
Columbia University

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.

Condition or disease Intervention/treatment Phase
Celiac Disease Drug: Rifaximin Drug: Placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind Randomized Controlled Trial of Rifaximin for Persistent Symptoms in Patients With Celiac Disease
Study Start Date : October 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease
Drug Information available for: Rifaximin

Arm Intervention/treatment
Experimental: Rifaximin
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

Primary Outcome Measures :
  1. 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 ]
    Validated seven point questionnaire that assesses gastrointestinal symptoms for five symptom areas, including abdominal pain, reflux, indigestion, diarrhea, and constipation.

Secondary Outcome Measures :
  1. To evaluate Lactulose hydrogen breath test improvement after administration of study drug, compared to baseline (week 0) [ Time Frame: 2 and 12 weeks ]
    Breath test that measures small intestine bacterial overgrowth.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  1. antibiotic use for any indication within preceding one month
  2. use of bismuth compounds within preceding month
  3. concomitant use of pancreatic supplements
  4. concomitant use of antispasmodics
  5. concomitant use of immunomodulators such as corticosteroids, budesonide, alkylating agents and antimetabolites.
  6. concomitant use of probiotics
  7. concomitant use of prokinetic agents
  8. concomitant use of 5HT3 antagonists, 5HT4 agonists
  9. concomitant use of antimotility agents (e.g loperamide)
  10. concomitant use of antidiarrheal agents
  11. diagnosed microscopic colitis or inflammatory bowel disease
  12. other causes of malabsorption: pancreatic insufficiency, giardiasis and enteropathy associated with T cell lymphoma.
  13. other diseases: renal or hepatic insufficiency.
  14. 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.
  15. patients with tuberculosis or a positive PPD test and infection with other mycobaterial diseases.
  16. allergy and/or potential emergence of drug resistance to rifampicin and rafamycin compounds.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01137955

United States, New York
Celiac Disease Center at Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Valeant Pharmaceuticals International, Inc.
Principal Investigator: Peter HR Green, MD Columbia University

Additional Information:
Responsible Party: Peter HR Green, Principal Investigator, Columbia University Medical Center Identifier: NCT01137955     History of Changes
Other Study ID Numbers: AAAB6531(Y3M00)
IRB-AAAB6531(Y3M00) ( Other Identifier: Columbia University Medical Center IRB )
First Posted: June 7, 2010    Key Record Dates
Last Update Posted: January 21, 2011
Last Verified: June 2010

Keywords provided by Columbia University:
Gastrointestinal Symptom Rating Scale (GSRS)
Poorly responsive
Small intestine bacterial overgrowth
Breath test

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents