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COMPLETED
NCT04364750
EARLY_PHASE1

Biomarkers of Diet-microbiota Interactions in Irritable Bowel Syndrome

Sponsor: McMaster University

View on ClinicalTrials.gov

Summary

Most patients suffering from the irritable bowel syndrome (IBS) report that ingestion of certain foods is a major trigger of symptoms, but the reason is unclear. Previous studies have shown that foods containing poorly absorbed carbohydrates (FODMAPs) are fermented by the bacteria in our bowels and these cause symptoms in some but not all patients. Gut bacteria are capable of producing various products, such as neuroimmune mediator histamine, that may be related to IBS symptoms. Our recent data suggest that consumption of FODMAPs promotes production of bacterial histamine. The main objective of this study is to investigate bacterial production of histamine and its relationship to IBS symptoms. The study will involve 6 weeks on a low-FODMAP diet with three three-day interventions consisting of High- or Low-FODMAP drinks along with probiotics or placebo capsules. The patient's bacteria and metabolites will be analyzed at various time points.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2021-07-15

Completion Date

2026-02-10

Last Updated

2026-04-13

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

L-Histidine

1 capsule (0.6g) twice daily

DIETARY_SUPPLEMENT

High-FODMAP beverage

High-FODMAP beverage (10g of fermentable carbohydrates) consumed twice daily.

DIETARY_SUPPLEMENT

Low-FODMAP beverage

Low-FODMAP beverage (10g glucose) consumed twice daily.

DIETARY_SUPPLEMENT

Lactobacillus acidophilus CL1285, L. casei LBC80R and L. rhamnosus CLR2.

Total of 50 billion CFU/capsule taken twice daily.

OTHER

Placebo

Enteric coated capsule with no active ingredient, taken twice daily

Locations (2)

McMaster University Medical Centre

Hamilton, Ontario, Canada

Kingston Health Sciences Centre

Kingston, Ontario, Canada