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Behavioural Intervention

Breath Analysis Device for Inflammatory Bowel Disease (AIRE-2 Trial)

N/A
Recruiting
Led By David Armstrong
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Age 18-75 years old, confirmed diagnosis of IBD (UC or CD)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to use a device called AIRE-2 and an app called FoodMarble to study how diet affects symptoms and gut microbes in patients with Inflammatory Bowel Disease (IBD)

Who is the study for?
This trial is for adults aged 18-75 with confirmed IBD in remission for at least 3 months, experiencing IBS-like symptoms. Participants must own a smartphone with Bluetooth and be fluent in English to use the app and provide consent.
What is being tested?
The study tests if the AIRE-2 breath analyzer and FoodMarble app can track diet, symptoms, and breath hydrogen/methane levels in IBD patients versus their household controls. It involves a low FODMAP diet followed by specific sugar challenges over four weeks.
What are the potential side effects?
Potential side effects may include gastrointestinal discomfort such as bloating or altered bowel habits due to dietary changes (low FODMAP diet) and intake of different sugars (Lactose, Fructose, Sorbitol, Inulin).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 75 years old with a confirmed IBD diagnosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proof of data collection/Adherence to the protocol
Secondary study objectives
Comparison of positive breath between IBD and non-IBD patients
Correlation of breath scores with food reported as being intolerant by the patients
Correlation of positive breath tests with severity of symptoms
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Case - Inflammatory Bowel DiseaseExperimental Treatment6 Interventions
Patients with IBD, under clinical remission since more than 3 months, having at least one symptom
Group II: Control - Healthy household memberActive Control6 Interventions
Family member of IBD patients who lives in the same house, shares similar diet and has no active GI disease or symptom
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
low FODMAP diet
2019
N/A
~80

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
918 Previous Clinical Trials
2,616,233 Total Patients Enrolled
David ArmstrongPrincipal InvestigatorMcMaster University
~40 spots leftby Sep 2027
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