Biomarkers of Diet-microbiota Interactions in Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

Biomarkers of Diet-microbiota Interactions in Irritable Bowel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04364750
• Other study ID #: BFIBS
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 15, 2021
• Est. completion date: April 2024

Study information

• Verified date: September 2023
• Source: McMaster University
• Contact: Caroline Seiler, BSc
• Phone: 9055212100
• Email: seilercl[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Adults aged 18-75 with IBS (Rome IV criteria) who have self-reported previous improvement in their IBS symptoms while on a low FODMAP diet, or when excluding certain high-FODMAP foods, or patients in whom histamine is expected to play a key role (either diagnosed with high histamine producing bacteria, or improved IBS symptoms after using antihistamines). Individuals should be able to swallow size 00 capsules.

Exclusion Criteria:

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

• Concurrent systemic disease (such as diabetes) and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection

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

• Pregnant or breastfeeding women

• Active or recent participation (< 1 month) in a clinical study, except for SPOR IMAGINE

• Use of antibiotics, probiotics, or ACE inhibitors during, or one month prior to the study

• Use of new medications less than 4 weeks prior to the study.

• Allergies to any of the ingredients used in the study

• Any immune-compromising conditions

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• L-Histidine
1 capsule (0.6g) twice daily
• High-FODMAP beverage
High-FODMAP beverage (10g of fermentable carbohydrates) consumed twice daily.
• Low-FODMAP beverage
Low-FODMAP beverage (10g glucose) consumed twice daily.
• 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

Country	Name	City	State
Canada	McMaster University Medical Centre	Hamilton	Ontario
Canada	Kingston Health Sciences Centre	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolites in stool, urine and blood	Metabolites will be measured by LC-MS and ELISA at baseline and before and after each intervention.	six weeks
Secondary	Expression of hdc gene by stool bacteria	Gram-positive and Gram-negative bacteria will be assessed by PCR using custom designed primers	six weeks
Secondary	Stool microbiota composition	16S rRNA Illumina sequencing of stool samples with culture-enriched sequencing.	six weeks
Secondary	Worsening of IBS symptoms following High-FODMAP challenge	Increase by =50 points on IBS Symptom Severity Score (IBS-SSS). The score will be used as a dichotomous variable. The overall score ranges from 0 to 500, with higher scores indicating greater symptom severity.	six weeks
Secondary	Changes in IBS symptoms	IBS-SSS continuous data. The overall score ranges from 0 to 500, with higher scores indicating greater symptom severity.	six weeks
Secondary	Changes in general GI symptoms	Patient-Reported Outcomes Measurement Information System (PROMIS) for general GI symptoms. Four subscales will be used: Gas & Bloating, Diarrhea, Constipation, and Belly Pain. T-scores are calculated using the Scoring Service by Health Measures and range from 34.7 - 79.0 (Gas & Bloating), 39.9 - 75.2 (Diarrhea), 40.6 - 80.8 (Constipation), and 33.9 - 80.0 (Belly Pain). On this scale, 50 indicates the mean of the general population and a difference of 10 is a standard deviation. Higher scores indicate greater symptom severity.	six weeks
Secondary	Levels of anxiety, depression and stress	Depression Anxiety Stress Scale (DASS-21) to assess psychiatric comorbidity and stress. The scale scores range from 0 - 42 with higher scores indicating worse outcomes.	six weeks
Secondary	Changes in dietary intake	5-day food diaries will be completed at 5 time points. FODMAP intake will be quantified using Monash University software and database	six weeks