What side effects are associated with this type of intervention?

Rifaximin, a non-absorbable antibiotic used to treat IBS, generally has mild and infrequent side effects such as nausea, increased liver enzymes, and headache. The Low FODMAP diet, which reduces poorly absorbed carbohydrates to alleviate symptoms, can lead to nutritional deficiencies if not properly managed and may cause initial digestive discomfort like bloating or changes in bowel habits. Both treatments require careful monitoring to minimize adverse effects and ensure efficacy.

What prior FDA approvals exist?

FDA-approved treatments for Irritable Bowel Syndrome (IBS) include rifaximin, an antibiotic that alters gut microbiota to reduce bacterial overgrowth and inflammation, specifically approved for IBS with diarrhea (IBS-D). The low FODMAP diet, although not a drug, is a dietary intervention that reduces poorly absorbed carbohydrates to alleviate symptoms. Other FDA-approved drugs for IBS include lubiprostone and linaclotide for IBS with constipation (IBS-C), and eluxadoline for IBS-D, each targeting different mechanisms to manage IBS symptoms.

What other types of research exist?

Promising novel alternatives for IBS treatment in 2024 include: 1) Ridinilazole, which has shown efficacy and safety in treating Clostridium difficile infection and may have potential for IBS due to its targeted antimicrobial properties. 2) Probiotics, which are being studied for their role in modulating gut microbiota and improving gastrointestinal symptoms. 3) Dietary interventions such as the Mediterranean diet, which has shown comparable remission rates to specific carbohydrate diets and may be easier to comply with.

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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

Must not have

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

Subjects with a history of GI tract surgery, except for cholecystectomy or appendectomy, will also be excluded from the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing an antibiotic and a special diet for people with a type of IBS that causes diarrhea. These patients often don't get better with current treatments. The antibiotic works by targeting gut bacteria, and the diet avoids certain sugars that can cause digestive problems. The antibiotic has been shown to be effective and safe for treating IBS with diarrhea in adults.

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not received dietary education or antibiotics for IBS-D.

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I have not had GI tract surgery, except possibly for gallbladder or appendix removal.

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I stopped taking probiotics at least a month ago.

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I have not taken antibiotics in the last 3 months.

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I have a condition like celiac or inflammatory bowel disease.

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I am not pregnant or breastfeeding.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement in Mean Daily Pain and/or Bloating

Secondary study objectives

IBS Symptom Severity Scale

Other study objectives

Fecal Microbiota

Glucose Breath Tests

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Rifaximin is a nonabsorbable antibiotic that alters the gut microbiota, reducing bacterial overgrowth and inflammation, which can alleviate symptoms such as bloating and diarrhea in IBS patients. The Low FODMAP Diet involves reducing the intake of poorly absorbed carbohydrates, which decreases gas production and alleviates symptoms like abdominal pain and bloating. These treatments are significant for IBS patients as they target underlying mechanisms—microbial imbalance and carbohydrate malabsorption—that contribute to the condition's symptoms, offering potential relief where other treatments may fail.

Clinical Management of the Microbiome in Irritable Bowel Syndrome.