Using a device to analyze breath in patients with inflammatory bowel diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective single-blinded intervention feasibility study aims to utilize the AIRE-2 device and FoodMarble app to explore the relationship between diet, symptoms, and microbial fermentation in patients with inflammatory bowel diseases (IBD) and their household controls. Participants will measure exhaled hydrogen and methane levels before and after meals while logging their dietary intake and symptoms over a five-week period. The study seeks to assess the feasibility of these tools in collecting relevant data and to gather preliminary insights into how diet impacts symptoms and gas production in IBD patients.

Why it matters

Who can join: the full rules

Inclusion criteria (IBD):

* Age 18-75 years old, confirmed diagnosis of IBD (UC or CD)
* Under clinical remission for at least 3 months
* Report having one or more IBS-like symptom (abdominal pain, altered bowel habit, flatulence, abdominal distension etc)
* Own a smartphone with Bluetooth capability
* Fluent in English.
* Able to understand the instructions to use smartphone apps
* Able to provide informed consent

Exclusion criteria (IBD):

* Use of antibiotics 1 month before enrolment
* Active IBD (disease activity score, fecal calprotectin, CRP)
* History of bowel resection
* Presence of a stoma
* Pregnancy
* Type 1 diabetes or insulin-dependent Type 2 diabetes
* Currently being treated for eating disorder, schizophrenia, psychosis or other acute mental disorder

A total of 30 adult IBD patients (18-75 years old), 15 ulcerative colitis (UC) and 15 Crohn's disease (CD) patients, will be recruited at the Digestive Diseases Clinic, McMaster University, Hamilton, Ontario.

Controls: A total of 30 non-IBD volunteers from the same household as the recruited IBD patients who do not have any IBS-like symptom will be recruited as controls.

Inclusion criteria:

* Age 18-75 years old, IBS-negative (Rome IV negative)
* Living in the same household as IBD patients, sharing a similar diet
* Asymptomatic
* Own a smartphone with Bluetooth capability
* Fluent in English.
* Able to understand the instructions to use smartphone apps
* Able to provide informed consent

Exclusion criteria:

* Diagnosed with IBD or other Gastrointestinal disorder
* Use of antibiotics 1 month before enrolment
* Pregnancy
* Type 1 diabetes or insulin-dependent Type 2 diabetes
* Currently being treated for eating disorder, schizophrenia, psychosis or other acute mental disorders.

Where it's running

• McMaster University Medical Centre
  Hamilton, Ontario, Canada Recruiting

Study contacts

• Principal investigator: David Armstrong — McMaster University
• Study coordinator: Anam Ahmed
• Email: ahmea195@mcmaster.ca
• Phone: 9055212100

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.