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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can swallow size 00 capsules.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Metabolites in stool, urine and blood
Secondary outcome measures
Changes in IBS symptoms
Changes in dietary intake
Changes in general GI symptoms
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Group CExperimental Treatment5 Interventions
Participants in group A will undergo challenges in the order:
High-FODMAP beverage + probiotic + L-Histidine
High-FODMAP beverage + placebo probiotic + L-Histidine
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:
Low-FODMAP beverage + placebo probiotic + L-Histidine
High-FODMAP beverage + probiotic + L-Histidine
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:
High-FODMAP beverage + placebo probiotic + L-Histidine
Low-FODMAP beverage + placebo probiotic + L-Histidine
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
Find a Location
Who is running the clinical trial?
McMaster UniversityLead Sponsor
880 Previous Clinical Trials
2,597,798 Total Patients Enrolled
6 Trials studying Irritable Bowel Syndrome
4,910 Patients Enrolled for Irritable Bowel Syndrome
Stephen Vanner, MDPrincipal InvestigatorQueens University
3 Previous Clinical Trials
1,020 Total Patients Enrolled
2 Trials studying Irritable Bowel Syndrome
220 Patients Enrolled for Irritable Bowel Syndrome
Premysl Bercik, MDPrincipal InvestigatorMcMaster University
4 Previous Clinical Trials
189 Total Patients Enrolled
3 Trials studying Irritable Bowel Syndrome
149 Patients Enrolled for Irritable Bowel Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I haven't had any cancer except for basal cell in the last 5 years.I am between 18-75 years old with IBS and have seen improvement on a low FODMAP diet or with antihistamines.I haven't started any new medications in the last 4 weeks.I have not taken antibiotics, probiotics, or ACE inhibitors in the last month.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.I am 18-75 years old with IBS and have seen improvement on a low FODMAP diet or with antihistamines.I can swallow size 00 capsules.
Research Study Groups:
This trial has the following groups:- Group 1: Group A
- Group 2: Group C
- Group 3: Group B
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate quantity of participants taking part in this trial?
"Affirmative. The information on clinicaltrials.gov demonstrates that this medical trial is actively searching for volunteers, having first been posted in July 2021 and most recently updated in February 2022. 30 individuals need to be enrolled from 2 different sites."
Answered by AI
Does the study admit people of octogenarian age or older?
"This medical trial allows for enrollees aged between 18 and 75, so long as all other criteria are met."
Answered by AI
Are there any open vacancies in this experiment for participants?
"Yes, it appears so. According to the data on clinicaltrials.gov, this medical study was initially posted on July 15th 2021 and most recently updated in February of 2022. The trial is looking for 30 participants between two sites."
Answered by AI
Do I qualify for this medical research project?
"This medical study is seeking 30 individuals, aged 18-75, that are suffering from IBS (as defined by the Rome IV criteria). Additionally, they must have shown improved symptoms while on a low FODMAP diet or after excluding certain high-FODMAP foods. Furthermore, those with an abundance of histamine producing bacteria and/or who experienced relief through antihistamines may also be suitable. Lastly, patients selected should not struggle swallowing size 00 capsules."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
Indiana
Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
McMaster University Medical Centre
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