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

June 6, 2022 updated by: Columbia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 (IUD), 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 5-hydroxytryptamine receptor (5HT3) antagonists,5-hydroxytryptamine receptor (5HT4) antagonists.
  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,intrauterine device.

    and double barrier methods.

  15. patients with tuberculosis or a positive purified protein derivative (PPD) test and infection with other mycobacterial diseases.
  16. allergy and/or potential emergence of drug resistance to rifampicin and rifamycin compounds.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rifaximin 400mg
Antibiotic ,Rifaximin 400mg, given 3 times a day for 10 days.
Drug: Rifaximin
Rifaximin 400mg orally three times a day for 10 days total
Other Names:
  • Placebo orally three times a day for 10 days total
Placebo Comparator: Placebo
Placebo pills given 3 times a day for 10 days.
Drug: Placebo
Placebo orally three times a day for 10 days total
Other Names:
  • Rifaximin 400 mg orally three times a day for 10 days total

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline Gastrointestinal Symptom Rating Scale (GSRS) Score
Time Frame: Baseline (week 0)
Validated seven point questionnaire that assesses gastrointestinal symptoms for five symptom areas, including abdominal pain, reflux, indigestion, diarrhea, and constipation. Individual scores are calculated for each symptom area and the mean of the scores is used to derive an overall GSRS score. Scores range from 0-7, with higher scores indicating gastrointestinal discomfort.
Baseline (week 0)
Week 2 Gastrointestinal Symptom Rating Scale (GSRS) Score
Time Frame: Week 2
Validated seven point questionnaire that assesses gastrointestinal symptoms for five symptom areas, including abdominal pain, reflux, indigestion, diarrhea, and constipation. Individual scores are calculated for each symptom area and the mean of the scores is used to derive an overall GSRS score. Scores range from 0-7, with higher scores indicating gastrointestinal discomfort.
Week 2
Week 12 Gastrointestinal Symptom Rating Scale (GSRS) Score
Time Frame: Week 12
Validated seven point questionnaire that assesses gastrointestinal symptoms for five symptom areas, including abdominal pain, reflux, indigestion, diarrhea, and constipation. Individual scores are calculated for each symptom area and the mean of the scores is used to derive an overall GSRS score. Scores range from 0-7, with higher scores indicating gastrointestinal discomfort.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Abnormal Breath Test
Time Frame: Up to 12 weeks
A breath test measures for small intestine bacterial overgrowth (SIBO). The breath test measures the amount of hydrogen exhaled after drinking a sugar (lactulose) solution. An abnormal breath test is defined as: 1) a rise in hydrogen of ≥20 parts per million (ppm) within 100 minutes, or 2) two peaks ≥20 ppm over baseline.
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Bausch Health Americas, Inc.

Investigators

  • Principal Investigator: Peter HR Green, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

June 3, 2010

First Submitted That Met QC Criteria

June 3, 2010

First Posted (Estimate)

June 7, 2010

Study Record Updates

Last Update Posted (Actual)

June 29, 2022

Last Update Submitted That Met QC Criteria

June 6, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAB6531
  • IRB-AAAB6531(Y3M00) (Other Identifier: Columbia University Medical Center IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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