Low FODMAP Diet for Irritable Bowel Syndrome

No longer recruiting at 1 trial location

Overseen By Vivian Cheng

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Antibiotics, Mast cell stabilizers, NSAIDs

Disqualifiers: Food allergy, Diabetes, Celiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a low FODMAP diet (low in certain carbohydrates that can cause digestive issues) can help people with irritable bowel syndrome, particularly those who primarily experience diarrhea. Researchers aim to understand how this diet affects the gut and improves symptoms. The trial seeks to determine if dietary changes can significantly benefit those struggling with IBS. Individuals who have experienced IBS with diarrhea for some time and have normal recent blood and stool tests might be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to valuable research that could lead to improved dietary recommendations for IBS sufferers.

Will I have to stop taking my current medications?

The trial requires that you do not regularly use certain medications like mast cell stabilizers, anti-histamines, NSAIDs (except daily baby aspirin), steroids, or bile-acid binders. If you are on these, you may need to stop taking them to participate.

What prior data suggests that the FODMAP diet is safe for individuals with IBS?

Research has shown that the low FODMAP diet is generally safe for people with IBS. Studies indicate that this diet can reduce symptoms in up to 86% of individuals with IBS by limiting certain hard-to-digest carbohydrates, which helps reduce bloating and diarrhea.

Evidence suggests that following this diet long-term is safe and manageable. However, not everyone experiences the same benefits, as about 25% of individuals may not see improvement. For most, though, the low FODMAP diet is well-tolerated and can effectively manage IBS symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The FODMAP diet is unique because it focuses on reducing certain types of carbohydrates that are poorly absorbed in the small intestine, which can trigger symptoms in people with Irritable Bowel Syndrome (IBS). Unlike medications that primarily aim to relieve symptoms like pain or diarrhea, this diet targets the root cause by altering the food intake to prevent symptoms from occurring in the first place. Researchers are excited about this approach because it offers a non-pharmacological option that empowers patients to manage their condition through dietary changes, potentially reducing reliance on medications and improving quality of life.

What evidence suggests that the FODMAP diet might be an effective treatment for IBS?

Studies have shown that a low FODMAP diet, which participants in this trial will follow, can be very effective for people with irritable bowel syndrome (IBS). Up to 86% of IBS patients report less abdominal pain and bloating when following this diet. Research indicates that the low FODMAP diet promotes healthier eating and significantly reduces IBS symptoms over time. One study found this diet highly effective in reducing symptoms like abdominal pain and bloating. Overall, many patients experience clear relief from IBS symptoms with a low FODMAP diet. ^{6 7 8 9 10}

Who Is on the Research Team?

Judy Nee, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with Irritable Bowel Syndrome (IBS), specifically those who often have diarrhea. Participants must have normal blood and stool test results, no C diff infections or parasites, and a certain score on an IBS symptom severity scale.

Inclusion Criteria

Tests for infections in your stool have to be normal.

Your blood tests for certain antibodies, thyroid hormone, inflammation, and blood cell counts are normal.

Your IBS-SSS score is 175 or higher after 7 days of screening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a low FODMAP diet to assess its effects on colonic permeability, microbiome, and immune cells

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FODMAP diet

Trial Overview

The study is testing the effects of a Low FODMAP Diet (LFD) on patients with IBS. The LFD aims to reduce symptoms by limiting foods that are high in certain sugars which can be hard to digest and may cause gut discomfort.

How Is the Trial Designed?

Group I: FODMAP diet Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

A low-FODMAP diet has been shown to significantly improve IBS symptoms in 52-86% of patients, making it a highly effective dietary intervention for this condition.

Patients who benefit from eliminating FODMAPs should follow a structured reintroduction process to identify specific food sensitivities, allowing for a personalized diet plan tailored to their needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-FODMAP Diet for Irritable Bowel Syndrome: What We Know and What We Have Yet to Learn. Liu, J., Chey, WD., Haller, E., et al.[2020]

A low FODMAP diet significantly improved symptoms in 90 IBS patients over an average follow-up of 15.7 months, with reductions in abdominal pain, bloating, flatulence, and diarrhea (p < 0.001 for all).

Patients with fructose malabsorption showed the greatest symptom improvement, and adherence to the low FODMAP diet was high (75.6%), correlating with better outcomes and satisfaction in 72.1% of participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The low FODMAP diet improves gastrointestinal symptoms in patients with irritable bowel syndrome: a prospective study. de Roest, RH., Dobbs, BR., Chapman, BA., et al.[2022]

The low-FODMAP diet can help alleviate symptoms of irritable bowel syndrome (IBS), such as bloating and diarrhea, but the evidence supporting its effectiveness is limited due to methodological flaws in studies, including a lack of proper control groups.

Prolonged use of the low-FODMAP diet may lead to nutritional deficiencies because it restricts many staple foods, potentially resulting in lower intake of essential nutrients like fiber, calcium, and vitamins, especially for those with limited access to alternative foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Low FODMAP Diet: Many Question Marks for a Catchy Acronym. Catassi, G., Lionetti, E., Gatti, S., et al.[2022]

The low FODMAP diet has been shown to improve symptoms of irritable bowel syndrome (IBS) by reducing the intake of short-chain fermentable carbohydrates that can trigger gastrointestinal discomfort.

While there is growing clinical evidence supporting the effectiveness of the low FODMAP diet for IBS, it is important to consider potential drawbacks and to implement the diet carefully under professional guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition in the management of gastrointestinal diseases and disorders: the evidence for the low FODMAP diet. Eswaran, S., Farida, JP., Green, J., et al.[2018]

In a study of 110 patients with diarrhea subtype of irritable bowel syndrome (IBS-D), a low FODMAP diet significantly improved gastrointestinal symptoms, stool frequency, and consistency compared to general dietary advice over a 6-week period.

Both dietary interventions led to symptom improvement, but the low FODMAP diet showed greater benefits, indicating it may be a more effective management strategy for IBS-D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low fermentable oligo-di-mono-saccharides and polyols diet versus general dietary advice in patients with diarrhea-predominant irritable bowel syndrome: A randomized controlled trial. Zahedi, MJ., Behrouz, V., Azimi, M.[2022]

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FODMAP Diet: What You Need to Know

The low FODMAP diet is part of the therapy for those with IBS and SIBO. Research has found that it reduces symptoms in up to 86% of people. Because the diet can ...

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Low Fodmap Diet: What it Is, Uses & How to Follow

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