Diet-Microbiota Interactions for Irritable Bowel Syndrome

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byPremysl Bercik, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: McMaster University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults aged 18-75 with IBS who've felt better on a low FODMAP diet or after cutting out high-FODMAP foods, or those whose symptoms improved with antihistamines. They must be able to swallow size 00 capsules and not have other significant GI diseases, systemic diseases like diabetes, active cancer in the last 5 years (except basal cell), be pregnant/breastfeeding, recently in another study, taking antibiotics/probiotics/ACE inhibitors recently, starting new meds within the last month, allergic to ingredients in the study drinks/capsules or have immune-compromising conditions.

Inclusion Criteria

I can swallow size 00 capsules.

I am between 18-75 years old with IBS and have seen improvement on a low FODMAP diet or with antihistamines.

Exclusion Criteria

Pregnant or breastfeeding women

I do not have major digestive system diseases like celiac or IBD.

I do not have any health conditions that could affect the study results.

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Treatment Details

Interventions

High-FODMAP beverage (DietarySupplement)
L-Histidine (DietarySupplement)
Low-FODMAP beverage (DietarySupplement)
Placebo (Other)
Probiotics (Probiotics)

Trial OverviewThe trial is testing how different beverages (high vs. low FODMAP) and probiotics affect gut bacteria and histamine production related to IBS symptoms over six weeks. Participants will follow a low-FODMAP diet while consuming these beverages along with either probiotics containing Lactobacillus strains or placebo capsules.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Group CExperimental Treatment5 Interventions

Participants in group A will undergo challenges in the order: 1. High-FODMAP beverage + probiotic + L-Histidine 2. High-FODMAP beverage + placebo probiotic + L-Histidine 3. Low-FODMAP beverage + placebo probiotic + L-Histidine. Challenges each last 5 days, but the FODMAP drinks and the L-Histidine capsules are only taken for the last three days. There is a 10 day washout period between challenges.

Group II: Group BExperimental Treatment5 Interventions

Participants in group A will undergo challenges in the order: 1. Low-FODMAP beverage + placebo probiotic + L-Histidine 2. High-FODMAP beverage + probiotic + L-Histidine 3. High-FODMAP beverage + placebo probiotic + L-Histidine. Challenges each last 5 days, but the FODMAP drinks and the L-Histidine capsules are only taken for the last three days. There is a 10 day washout period between challenges.

Group III: Group AExperimental Treatment5 Interventions

Participants in group A will undergo challenges in the order: 1. High-FODMAP beverage + placebo probiotic + L-Histidine 2. Low-FODMAP beverage + placebo probiotic + L-Histidine 3. High-FODMAP beverage + probiotic + L-Histidine Challenges each last 5 days, but the FODMAP drinks and the L-Histidine capsules are only taken for the last three days. There is a 10 day washout period between challenges.