NCT04364750

Biomarkers of Diet-microbiota Interactions in Irritable Bowel Syndrome

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-07-15
• Primary completion: 2026-02-10
• Completion: 2026-02-10
• First posted: 2020-04-28
• Last updated: 2026-04-13

Locations

2 sites across 1 country: Canada