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Diet-Microbiota Interactions for Irritable Bowel Syndrome

Phase < 1

Recruiting

Led By Stephen Vanner, MD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals should be able to swallow size 00 capsules

Be older than 18 years old

Must not have

Concurrent significant organic GI pathology (i.e. celiac, IBD, etc.)

History of active cancer in the last 5 years, other than basal cell cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six weeks

Summary

This trial will help to understand how FODMAPs affect IBS symptoms by looking at the production of histamine by gut bacteria.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Possible side effects may include typical digestive issues such as gas, bloating, discomfort from high-FODMAP drinks; reactions to probiotics like stomach upset; and any individual intolerance to components of the test products.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow size 00 capsules.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I haven't had any cancer except for basal cell in the last 5 years.

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I have not taken antibiotics, probiotics, or ACE inhibitors in the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ six weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~six weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and six weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Metabolites in stool, urine and blood

Secondary study objectives

Changes in IBS symptoms

Changes in dietary intake

Changes in general GI symptoms

+4 more

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

L-Histidine

2018

Completed Phase 1

~20

0 / 4Eligibility criteria met