Back to results

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

Primary Purpose

Irritable Bowel Syndrome

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Rifaximin 550 MG

Low FODMAP Diet

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Diarrhea, Small Intestinal Bacterial Overgrowth, Gut Microbiota

Eligibility Criteria

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

Inclusion Criteria:

Adult subjects greater than or equal to 18 years of age who meet Rome IV criteria for diarrhea-predominant irritable bowel syndrome (IBS-D).

Prior colonoscopy or sigmoidoscopy within the past 2 years with random colon biopsies to exclude the presence of microscopic colitis.

IBS medications, including anti-depressants, will be allowed if the dose has been stable for at least 1 month before inclusion. Medications will be carefully tracked to follow any potential confounding issues.

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 cholecystectomy or appendectomy, will also be excluded from the study.

Women who are pregnant or breastfeeding 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 will be excluded from the study.

Sites / Locations

University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Rifaximin

Low FODMAP Group

Arm Description

Rifaximin 550 mg three times daily for 14 days

Low FODMAP diet for 4 weeks

Outcomes

Primary Outcome Measures

Improvement in Mean Daily Pain and/or Bloating

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

IBS Symptom Severity Scale

Secondary outcomes will be defined by reduction in IBS Symptom Severity Scale by ≥ 50 compared with baseline.

Full Information

NCT ID

NCT03219528

First Posted

July 13, 2017

Last Updated

November 27, 2022

Sponsor

University of Michigan

Collaborators

Michigan Institute for Clinical and Health Research (MICHR)

1. Study Identification

Unique Protocol Identification Number

NCT03219528

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 13, 2018 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

Michigan Institute for Clinical and Health Research (MICHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome, Diarrhea, Small Intestinal Bacterial Overgrowth, Gut Microbiota

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rifaximin

Arm Type

Active Comparator

Arm Description

Rifaximin 550 mg three times daily for 14 days

Arm Title

Low FODMAP Group

Arm Type

Active Comparator

Arm Description

Low FODMAP diet for 4 weeks

Intervention Type

Drug

Intervention Name(s)

Rifaximin 550 MG

Intervention Description

Rifaximin 550 mg three times daily for 14 days

Intervention Type

Other

Intervention Name(s)

Low FODMAP Diet

Intervention Description

Low FODMAP dietary intervention for 4 weeks

Primary Outcome Measure Information:

Title

Improvement in Mean Daily Pain and/or Bloating

Description

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

IBS Symptom Severity Scale

Description

Secondary outcomes will be defined by reduction in IBS Symptom Severity Scale by ≥ 50 compared with baseline.

Time Frame

4 weeks

Other Pre-specified Outcome Measures:

Title

Glucose Breath Tests

Description

Glucose breath tests (GBT) will be performed at baseline and repeated after intervention

Time Frame

4 weeks

Title

Fecal Microbiota

Description

Changes in fecal microbial diversity after intervention will be compared with baseline.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult subjects greater than or equal to 18 years of age who meet Rome IV criteria for diarrhea-predominant irritable bowel syndrome (IBS-D). Prior colonoscopy or sigmoidoscopy within the past 2 years with random colon biopsies to exclude the presence of microscopic colitis. IBS medications, including anti-depressants, will be allowed if the dose has been stable for at least 1 month before inclusion. Medications will be carefully tracked to follow any potential confounding issues. 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 cholecystectomy or appendectomy, will also be excluded from the study. Women who are pregnant or breastfeeding 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 will be excluded from the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Allen Lee, MD

Phone

(734) 936-9454

allenlee@umich.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allen Lee, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Deepa Chandhrasekhar

First Name & Middle Initial & Last Name & Degree

Amy Liu

First Name & Middle Initial & Last Name & Degree

Allen Lee

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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.

Citations:

PubMed Identifier

21208106

Citation

Pimentel M, Lembo A, Chey WD, Zakko S, Ringel Y, Yu J, Mareya SM, Shaw AL, Bortey E, Forbes WP; TARGET Study Group. Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med. 2011 Jan 6;364(1):22-32. doi: 10.1056/NEJMoa1004409.

Results Reference

background

PubMed Identifier

27528177

Citation

Lembo A, Pimentel M, Rao SS, Schoenfeld P, Cash B, Weinstock LB, Paterson C, Bortey E, Forbes WP. Repeat Treatment With Rifaximin Is Safe and Effective in Patients With Diarrhea-Predominant Irritable Bowel Syndrome. Gastroenterology. 2016 Dec;151(6):1113-1121. doi: 10.1053/j.gastro.2016.08.003. Epub 2016 Aug 13.

Results Reference

background

PubMed Identifier

26255043

Citation

Bohn L, Storsrud S, Liljebo T, Collin L, Lindfors P, Tornblom H, Simren M. Diet low in FODMAPs reduces symptoms of irritable bowel syndrome as well as traditional dietary advice: a randomized controlled trial. Gastroenterology. 2015 Nov;149(6):1399-1407.e2. doi: 10.1053/j.gastro.2015.07.054. Epub 2015 Aug 5.

Results Reference

background

PubMed Identifier

27725652

Citation

Eswaran SL, Chey WD, Han-Markey T, Ball S, Jackson K. A Randomized Controlled Trial Comparing the Low FODMAP Diet vs. Modified NICE Guidelines in US Adults with IBS-D. Am J Gastroenterol. 2016 Dec;111(12):1824-1832. doi: 10.1038/ajg.2016.434. Epub 2016 Oct 11.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs