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

Primary Purpose

Celiac Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rifaximin
Placebo
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring Gastrointestinal Symptom Rating Scale (GSRS), Poorly responsive, Refractory, Small intestine bacterial overgrowth, Breath test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Celiac Disease Center at Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rifaximin 400mg

Placebo

Arm Description

Antibiotic ,Rifaximin 400mg, given 3 times a day for 10 days.

Placebo pills given 3 times a day for 10 days.

Outcomes

Primary Outcome Measures

Baseline Gastrointestinal Symptom Rating Scale (GSRS) Score
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 Gastrointestinal Symptom Rating Scale (GSRS) Score
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 Gastrointestinal Symptom Rating Scale (GSRS) Score
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.

Secondary Outcome Measures

Percentage of Participants With Abnormal Breath Test
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.

Full Information

First Posted
June 3, 2010
Last Updated
June 6, 2022
Sponsor
Columbia University
Collaborators
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01137955
Brief Title
Rifaximin for the Treatment of Persistent Symptoms in Patients With Celiac Disease
Official Title
Double-blind Randomized Controlled Trial of Rifaximin for Persistent Symptoms in Patients With Celiac Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
Gastrointestinal Symptom Rating Scale (GSRS), Poorly responsive, Refractory, Small intestine bacterial overgrowth, Breath test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rifaximin 400mg
Arm Type
Experimental
Arm Description
Antibiotic ,Rifaximin 400mg, given 3 times a day for 10 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo pills given 3 times a day for 10 days.
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Other Intervention Name(s)
Placebo orally three times a day for 10 days total
Intervention Description
Rifaximin 400mg orally three times a day for 10 days total
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Rifaximin 400 mg orally three times a day for 10 days total
Intervention Description
Placebo orally three times a day for 10 days total
Primary Outcome Measure Information:
Title
Baseline Gastrointestinal Symptom Rating Scale (GSRS) Score
Description
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.
Time Frame
Baseline (week 0)
Title
Week 2 Gastrointestinal Symptom Rating Scale (GSRS) Score
Description
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.
Time Frame
Week 2
Title
Week 12 Gastrointestinal Symptom Rating Scale (GSRS) Score
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With Abnormal Breath Test
Description
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.
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 (IUD), 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 5-hydroxytryptamine receptor (5HT3) antagonists,5-hydroxytryptamine receptor (5HT4) antagonists. 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,intrauterine device. and double barrier methods. patients with tuberculosis or a positive purified protein derivative (PPD) test and infection with other mycobacterial diseases. allergy and/or potential emergence of drug resistance to rifampicin and rifamycin compounds.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter HR Green, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Celiac Disease Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21647654
Citation
Chang MS, Minaya MT, Cheng J, Connor BA, Lewis SK, Green PH. Double-blind randomized controlled trial of rifaximin for persistent symptoms in patients with celiac disease. Dig Dis Sci. 2011 Oct;56(10):2939-46. doi: 10.1007/s10620-011-1719-6. Epub 2011 Jun 7.
Results Reference
result

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

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