Effects of Low FODMAP Diet on Leaky Gut

Irritable Bowel Syndrome Clinical Trial

Official title:

Effects of Low FODMAP Diet on Leaky Gut and Mucosal Immune Cell Abundance in Diarrhea-predominant Irritable Bowel Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04526808
• Other study ID #: 2019P000149
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: June 1, 2025

Study information

• Verified date: December 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• aged 18-65 years at the time of screening

• normal serum studies including serum tissue-transglutaminase antibodies, thyroid stimulating hormone levels, C-reactive protein, complete blood count since the onset of symptoms

• normal stool studies including C diff testing, culture, ova and parasites since the onset of symptoms

• IBS-SSS score of =175 at the end of 7-day screening period

Exclusion criteria:

• individuals already on a LFD or other dietary restriction such as gluten free diet within the past 6 months

• individuals with any known food allergy or insulin-dependent diabetes

• known history of celiac disease, inflammatory bowel disease or microscopic colitis

• prior small bowel or colonic surgery or cholecystectomy

• pregnant patients

• antibiotics in the past 3 months

• those who regularly use mast cell stabilizers or anti-histaminic or non-steroidal anti-inflammatory agents (NSAIDs) excluding daily baby aspirin or steroids or bile-acid binder.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Other:
• FODMAP diet
low FODMAP diet

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	colonic permeability	Lactulose:Mannitol ratio pre and post treatment	4 weeks
Secondary	colonic immune cells	expression of tight junction proteins pre and post treatment using RT-PCR	4 weeks
Secondary	colonic microbiome	relative stool microbial abundance pre and post treatment measured using 16s RNA	4 weeks