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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Device
Study Type: Interventional
Study Phase: Not Applicable
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 fermentable features in IBD patients with persistent intestinal symptoms and their household controls. AIRE-2 captures exhaled hydrogen and methane and FoodMarble app records breath levels, symptoms and dietary intake. The main questions it aims to answer are: 1. To assess the feasibility of using the AIRE-2 device, FoodMarble mobile app in a cohort of IBD patients and their household controls to collect data on diet, symptoms and exhaled H2 and CH4 levels. 2. 2. To assess the feasibility of using FoodMarble's FODMAP discovery kit protocol in a cohort of IBD patients and their household controls. 3. To collect preliminary data on the relation between diet, symptoms, and exhaled H2 and CH4 levels measured by the AIRE-2 device and FoodMarble app in a cohort of IBD patients and their household controls. 4. To explore the correlation between the fecal microbiome sequencing profile with exhaled H2 and CH4 levels, diet and symptoms in a cohort of IBD patients and their household controls. You will: 1. Record regular diet in the FoodMarble app and collect baseline stool samples 2. You will then take a low FODMAP diet for 24 hours every week and record the diet and symptoms. After the diet, you will take the FODMAP challenge of Lactose, Fructose, Sorbitol and Inulin (one every week) using Sachets provided by FoodMarble company, record exhaled breath levels, symptoms and collect stool. This process will take 4 weeks. 3. Visit clinic to submit stool samples

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• 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

• 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

Locations
Other Locations
Canada
McMaster University Medical Centre
RECRUITING
Hamilton
Contact Information
Primary
Anam Ahmed
ahmea195@mcmaster.ca
9055212100
Time Frame
Start Date: 2024-08-28
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Case - Inflammatory Bowel Disease
Patients with IBD, under clinical remission since more than 3 months, having at least one symptom
Active_comparator: Control - Healthy household member
Family member of IBD patients who lives in the same house, shares similar diet and has no active GI disease or symptom
Related Therapeutic Areas
Sponsors
Leads: McMaster University

This content was sourced from clinicaltrials.gov