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

This study has been completed.
Sponsor:
Collaborator:
Salix Pharmaceuticals
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT01137955
First received: June 3, 2010
Last updated: January 19, 2011
Last verified: June 2010
  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:


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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Malabsorption Syndromes
Metabolic Diseases
Rifaximin
Anti-Infective Agents
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014