Low FODMAP Diet for Irritable Bowel Syndrome

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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The pathophysiology of Irritable bowel syndrome (IBS) is multifactorial involving complex interplay of altered intestinal permeability, mucosal immune activation, visceral hypersensitivity and gut dysbiosis. Although the exact triggers for these pathological changes in IBS are not clear but diet might play an important role. In fact, several studies have reported improvement in gastrointestinal symptoms on a diet low in FODMAPs (LFD) in patients with IBS, specifically in diarrhea predominant IBS (IBS-D). However, the mechanism of action of LFD is not well understood.

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 data supports the effectiveness of the low FODMAP diet treatment for irritable bowel syndrome?

Research shows that 52-86% of people with irritable bowel syndrome (IBS) experience significant improvement in their symptoms when they follow a low FODMAP diet, which involves reducing certain types of carbohydrates that can cause digestive issues. ^{1 2 3 4 5}

Is the low FODMAP diet safe for humans?

The low FODMAP diet is generally considered safe for short-term use, but there are concerns about its nutritional adequacy and potential impact on gut bacteria if not managed properly. It's recommended to follow this diet under the guidance of a trained dietitian to minimize risks. ^{6 7 8 9 10}

How does the low FODMAP diet treatment differ from other treatments for irritable bowel syndrome?

The low FODMAP diet is unique because it involves reducing certain carbohydrates that are poorly absorbed and can cause symptoms in people with IBS. Unlike other treatments, it starts with a 6-week elimination phase followed by a gradual reintroduction of foods, which helps identify specific triggers for each individual. ^{11 12 13 14 15}

Research Team

Judy Nee, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

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.

I am between 18 and 65 years old.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Low-FODMAP Diet for Irritable Bowel Syndrome: What We Know and What We Have Yet to Learn. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Long-term impact of the low-FODMAP diet on gastrointestinal symptoms, dietary intake, patient acceptability, and healthcare utilization in irritable bowel syndrome. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Randomised clinical trial: the efficacy of gut-directed hypnotherapy is similar to that of the low FODMAP diet for the treatment of irritable bowel syndrome. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Nutrition in the management of gastrointestinal diseases and disorders: the evidence for the low FODMAP diet. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Dietary Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols (FODMAPs) and Gastrointestinal Disease. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

The Impact of a 4-Week Low-FODMAP and mNICE Diet on Nutrient Intake in a Sample of US Adults with Irritable Bowel Syndrome with Diarrhea. [2020]

7. Spain pubmed.ncbi.nlm.nih.gov

[Is the diet low in FODMAP really effective and safe for irritable bowel syndrome?: A scoping review]. [2021]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Low Fermentable Oligo-, Di- and Monosaccharides and Polyols (FODMAP) diet in the treatment of patients with irritable bowel syndrome: basic principles and methodology]. [2021]

9. Australia pubmed.ncbi.nlm.nih.gov

Controversies and reality of the FODMAP diet for patients with irritable bowel syndrome. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Low fermentable, oligo-, di-, mono-saccharides and polyol diet in the treatment of irritable bowel syndrome: A systematic review and meta-analysis. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

[The low FODMAP diet as a therapy for irritable bowel syndrome]. [2018]

12. Australia 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. [2022]

13. India pubmed.ncbi.nlm.nih.gov

The low FODMAP diet improves gastrointestinal symptoms in patients with irritable bowel syndrome: a prospective study. [2022]

14. Switzerland pubmed.ncbi.nlm.nih.gov

The Low FODMAP Diet: Many Question Marks for a Catchy Acronym. [2022]

15. England pubmed.ncbi.nlm.nih.gov

Low FODMAP diet in irritable bowel syndrome: a review of recent clinical trials and meta-analyses. [2023]