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A Longitudinal Study to Identify IBS Phenotypes Using Fecal Microbiota and Hydrogen Breath Testing

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ClinicalTrials.gov Identifier: NCT03219528
Recruitment Status : Recruiting
First Posted : July 17, 2017
Last Update Posted : October 23, 2017
Sponsor:
Collaborator:
Michigan Institute for Clinical and Health Research (MICHR)
Information provided by (Responsible Party):
Allen Lee, University of Michigan

Brief Summary:
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a highly prevalent but poorly understood condition with limited treatment options. Current therapies, including a nonabsorbable antibiotic rifaximin or diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP), show efficacy in 50% or less of patients. In this proposal, we will randomize IBS-D patients to receive either rifaximin or low FODMAP dietary intervention.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: Rifaximin 550 MG Other: Low FODMAP Diet Phase 4

Detailed Description:
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a highly prevalent but poorly understood condition with limited treatment options. Recent evidence has established small intestinal bacterial overgrowth (SIBO) and alterations in fecal microbiota as potential etiologies in the pathogenesis of IBS-D. Current therapies, including a nonabsorbable antibiotic rifaximin or diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP), show efficacy in 50% or less of patients [1-4]. It has been postulated that limited responses to therapies may stem from failure to identify distinct subgroups in IBS-D stratified by gut microbial profiles. In this proposal, we will randomize IBS-D patients to receive either rifaximin or low FODMAP dietary intervention. We will then longitudinally follow the results of fecal microbiota-derived data as well as hydrogen breath tests to define SIBO. We will use these methods to test the hypotheses that: (i) distinct IBS-D phenotypes can be generated by defining fecal microbial populations as well as delineating the presence or absence of SIBO; and (ii) longitudinal analyses using microbe-derived metrics and SIBO status may relate to response to treatment with rifaximin or low FODMAP dietary intervention.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Longitudinal Study to Identify IBS Phenotypes Using Fecal Microbiota and Hydrogen Breath Testing
Actual Study Start Date : October 19, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin

Arm Intervention/treatment
Active Comparator: Rifaximin
Rifaximin 550 mg three times daily for 14 days
Drug: Rifaximin 550 MG
Rifaximin 550 mg three times daily for 14 days

Active Comparator: Low FODMAP Group
Low FODMAP diet for 4 weeks
Other: Low FODMAP Diet
Low FODMAP dietary intervention for 4 weeks




Primary Outcome Measures :
  1. Improvement in Mean Daily Pain and/or Bloating [ Time Frame: 4 weeks ]
    The primary outcome will be changes in mean daily pain or bloating by visual analog scale (VAS) after intervention compared with baseline. Responders to intervention will be defined by ≥ 30% reductions in mean daily pain or bloating by VAS compared with baseline.


Secondary Outcome Measures :
  1. IBS Symptom Severity Scale [ Time Frame: 4 weeks ]
    Secondary outcomes will be defined by reduction in IBS Symptom Severity Scale by ≥ 50 compared with baseline.


Other Outcome Measures:
  1. Glucose Hydrogen Breath Tests [ Time Frame: 4 weeks ]
    Glucose hydrogen breath tests (GHBT) will be performed at baseline and repeated after intervention

  2. Fecal Microbiota [ Time Frame: 4 weeks ]
    Changes in fecal microbial diversity after intervention will be compared with baseline.



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

Inclusion Criteria:

  • Adult subjects > or = 18 years of age who meet Rome IV criteria for IBS-D
  • Prior colonoscopy or sigmoidoscopy within the past 2 years with random colon biopsies to exclude the presence of microscopic colitis

Exclusion Criteria:

  • Underlying celiac disease, inflammatory bowel disease, or other organic disease that could explain their symptoms.
  • Subjects with a history of GI tract surgery, except for appendectomy, will also be excluded from the study.
  • Antibiotics taken within 3 months prior to enrollment will not be permitted.
  • Subjects on probiotics must discontinue their use at least 1 month prior to enrollment.
  • Subjects who have previously received formal dietary education for IBS, including a low FODMAP diet, or previously received antibiotics, including rifaximin, for treatment of IBS-D or SIBO will be excluded from the study.

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 ClinicalTrials.gov identifier (NCT number): NCT03219528


Contacts
Contact: Allen Lee, MD (734) 936-9454 allenlee@umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Deepa Chandhrasekhar         
Contact: Sam Olson         
Principal Investigator: Allen Lee         
Sponsors and Collaborators
University of Michigan
Michigan Institute for Clinical and Health Research (MICHR)
Investigators
Principal Investigator: Allen Lee, MD University of Michigan

Publications:
Responsible Party: Allen Lee, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT03219528     History of Changes
Other Study ID Numbers: HUM129427
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All investigators are aware of and agree to abide by the principles for sharing research resources, as described by NIH in "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Programs." The data generated in this study will be shared in several ways. Manuscripts will be submitted for publication in high-quality peer-reviewed journals. Findings will also be presented at relevant national meetings, including Digestive Disease Week and Association of Clinical and Translational Science.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Allen Lee, University of Michigan:
Irritable Bowel Syndrome
Diarrhea
Small Intestinal Bacterial Overgrowth
Gut Microbiota

Additional relevant MeSH terms:
Colonic Diseases, Functional
Irritable Bowel Syndrome
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rifaximin
Rifamycins
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents