AIRE-2 Device for Study of Breath Analysis in IBD
NCT Number: NCT06541938
Acronym: AIRE-2
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Inflammatory Bowel Diseases
Interventions: DIETARY_SUPPLEMENT: low FODMAP diet|DIETARY_SUPPLEMENT: Lactose Sachet|DIETARY_SUPPLEMENT: Fructose Sachet|DIETARY_SUPPLEMENT: Sorbitol Sachet|DIETARY_SUPPLEMENT: Inulin Sachet|DEVICE: AIRE-2 Portable breath analyzer
Sponsor: McMaster University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-08-15
Completion Date: 2027-12-31

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

Primary Outcome Measures: Proof of data collection/Adherence to the protocol, For each data set, we will divide the number of logged data divided by the total data expected to be logged. For example, the number of breath tests using AIRE-2 logged by the participant / total expected. This will also apply to the diet log. The results will be expressed in %., 40 months
Secondary Outcome Measures: Comparison of positive breath between IBD and non-IBD patients, average of # \>3 breath test score / total group #, 40 months|Prevalence of positive score with symptoms between IBD and non-IBD patients, # of events when \>3 breath test score match with symptomatic event / total positive test events, 40 months|Correlation of positive breath tests with severity of symptoms, using person correlation coefficient, 40 months|Correlation of breath scores with food reported as being intolerant by the patients, matching between reported dietary triggers at baseline and positive breath test, 40 months|Microbiome taxa, We will explore the correlation between the presence of microbiome genera with the exhaled H2 and CH4 scores. The microbiome profile will be done by 16S rRNA sequencing of fecal samples., 40 months|Relative abundance of predicted microbial metabolic pathways, Microbial metabolic pathways will be predicted using PICRUSt and correlated with dietary intake and breath test results, 40 months