Status:
UNKNOWN
Biomarkers of Diet-microbiota Interactions in Irritable Bowel Syndrome
Lead Sponsor:
McMaster University
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04364750
Start Date
July 15 2021
End Date
April 1 2024
Last Update
September 26 2023
Active Locations (2)
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1
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
2
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7