Using a device to analyze breath in patients with inflammatory bowel diseases
A Feasibility Study to Use a Handheld, In-Home Breath Test Device to Measure H2 and CH4 Production from Carbohydrate Fermentation and Its Correlation with Persistent Symptoms in Inflammatory Bowel Disease Patients in Remission
This study is testing a device that measures breath to see how diet affects symptoms and gas production in people with inflammatory bowel diseases and their family members.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT06541938 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 with a confirmed diagnosis of IBD who are in clinical remission and experience IBS-like symptoms.
Not a fit: Patients with active IBD, recent antibiotic use, or certain medical conditions such as diabetes or mental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into dietary management for patients with inflammatory bowel diseases, potentially improving their quality of life.
How similar studies have performed: While the specific use of the AIRE-2 device and FoodMarble app is novel, similar studies exploring diet and breath analysis in gastrointestinal conditions have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hamilton, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.