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Rifaximin + Low FODMAP Diet for Irritable Bowel Syndrome

Phase 4

Waitlist Available

Led By Allen Lee, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

Study Summary

This trial will compare the effectiveness of two treatments for diarrhea-predominant irritable bowel syndrome (IBS-D). Half of the patients will receive the antibiotic rifaximin, while the other half will follow a low FODMAP diet.

Who is the study for?

This trial is for adults diagnosed with diarrhea-predominant irritable bowel syndrome (IBS-D) who meet specific criteria. They must have had a colonoscopy or sigmoidoscopy within the last 2 years and can be on stable IBS medication doses for at least 1 month. Pregnant or breastfeeding women, those with recent GI surgery (except cholecystectomy/appendectomy), antibiotic use in the past 3 months, prior low FODMAP diet education, or previous rifaximin treatment are excluded.Check my eligibility

What is being tested?

The study compares two treatments for IBS-D: Rifaximin, a nonabsorbable antibiotic, versus a Low FODMAP Diet that limits certain carbohydrates. Patients will be randomly assigned to one of these interventions to see which is more effective in managing their symptoms.See study design

What are the potential side effects?

Rifaximin may cause side effects like nausea, an increase in liver enzymes, fatigue, and dizziness. The Low FODMAP Diet might lead to changes in diet satisfaction and could potentially affect nutrition intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 or older with IBS-D diagnosed by Rome IV criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Improvement in Mean Daily Pain and/or Bloating

Secondary outcome measures

IBS Symptom Severity Scale

Other outcome measures

Fecal Microbiota

Glucose Breath Tests

Trial Design

2Treatment groups

Active Control

Group I: RifaximinActive Control1 Intervention

Rifaximin 550 mg three times daily for 14 days

Group II: Low FODMAP GroupActive Control1 Intervention

Low FODMAP diet for 4 weeks

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Michigan Institute for Clinical and Health Research (MICHR)UNKNOWN

1 Previous Clinical Trials

1 Total Patients Enrolled

University of MichiganLead Sponsor

1,800 Previous Clinical Trials

6,379,076 Total Patients Enrolled

12 Trials studying Irritable Bowel Syndrome

888 Patients Enrolled for Irritable Bowel Syndrome

Allen Lee, MDPrincipal Investigator - University of Michigan

University of Michigan C.S. Mott Children's Hospital, University of Michigan Health System, Von Voigtlander Women's Hospital

3 Previous Clinical Trials

102 Total Patients Enrolled

Media Library

Low FODMAP Diet Clinical Trial Eligibility Overview. Trial Name: NCT03219528 — Phase 4

Irritable Bowel Syndrome Research Study Groups: Rifaximin, Low FODMAP Group

Irritable Bowel Syndrome Clinical Trial 2023: Low FODMAP Diet Highlights & Side Effects. Trial Name: NCT03219528 — Phase 4

Low FODMAP Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT03219528 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity of this trial for patient enrollment?

"Affirmative. According to the clinicaltrials.gov webpage, this medical research is currently accepting applicants with recruitment beginning on February 13th 2018 and last updated November 27th 2022 for a total of 64 participants at one single site."

Answered by AI

Are there any opportunities presently to register for the trial?

"Affirmative, the clinicaltrial.gov website attests that this study is currently accepting volunteers. This health trial was originally advertised on February 13th 2018 and last modified November 27th 2022. The researchers are expecting to recruit 64 individuals from a single clinic site."

Answered by AI

What indications does Rifaximin typically target?

"As a commonly used treatment for the reoccurrence of clostridium difficile infection, rifaximin has also been known to beneficially affect patients suffering from irritable bowel syndrome (IBS), bacterial infections and diarrhoea."

Answered by AI

What safety protocols are in place for patients taking Rifaximin?

"There is ample evidence of safety associated with Rifaximin, rendering it a score of 3 on the scale. This treatment has been approved by medical authorities and is undergoing Phase 4 trials."

Answered by AI