Status:
RECRUITING
AIRE-2 Device for Study of Breath Analysis in IBD
Lead Sponsor:
McMaster University
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The goal of this Prospective single-blinded intervention feasibility study is the utilization of the AIRE-2 device and FoodMarble app to elucidate the interplay among diet, symptoms, and microbial fer...
Detailed Description
Study Design Type: Prospective single-blinded intervention feasibility study Methodology/Study Design: A cohort of IBD patients and their healthy household controls will be recruited for this study...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06541938
Start Date
August 28 2024
End Date
December 31 2027
Last Update
November 25 2024
Active Locations (1)
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1
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5