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

NCT01137955 | Completed Results DMC

• 2 other identifiers: AAAB6531IRB-AAAB6531(Y3M00)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline (week 0)

• 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 2

• 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.

  Week 12

Secondary Outcomes (1)

• Percentage of Participants With Abnormal Breath Test

  Up to 12 weeks

Study Arms (2)

Rifaximin 400mg

EXPERIMENTAL

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

Drug: Rifaximin

Placebo

PLACEBO COMPARATOR

Placebo pills given 3 times a day for 10 days.

Drug: Placebo

Interventions

Rifaximin DRUG

Rifaximin 400mg orally three times a day for 10 days total

Also known as: Placebo orally three times a day for 10 days total

Rifaximin 400mg

Placebo DRUG

Placebo orally three times a day for 10 days total

Also known as: Rifaximin 400 mg orally three times a day for 10 days total

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• Bausch Health Americas, Inc.: collaborator

Study Sites (1)

Celiac Disease Center at Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 21647654 RESULT

MeSH Terms

Conditions

Celiac Disease

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

Small sample size. Challenges of diagnosing bacterial overgrowth.

Results Point of Contact

• Title: Dr. Peter Green
• Organization: Celiac Disease Center at Columbia University

mtm2111@columbia.edu

(212) 305-5590

Study Officials

• Peter HR Green, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 7, 2010
• Study Start: October 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 29, 2022
• Results First Posted: June 29, 2022

Record last verified: 2022-06

Locations

US (1)