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AIRE-2 Device for Study of Breath Analysis in IBD

Inflammatory Bowel Diseases

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

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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    18 to 75

Critères de participation

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.

Lieu de l'étude

McMaster University Medical Centre
McMaster University Medical Centre
Hamilton, Ontario
Canada

Contactez l'équipe d'étude

Étude parrainée par
McMaster University
Participants recherchés
Plus d'informations
ID de l'étude: NCT06541938