Recruiting

AIRE-2 DeviceAIRE-2 Device for Study of Breath Analysis in IBD

Sponsor:

McMaster University

Code:

NCT06541938

Conditions

Inflammatory Bowel Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

low FODMAP diet

Lactose Sachet

Fructose Sachet

Sorbitol Sachet

Inulin Sachet

Study Details

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 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

Conditions

Inflammatory Bowel Diseases

Study ID

NCT06541938

Start date

Aug 28, 2024

Status verified date

Nov, 2024

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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

Interventions

low FODMAP diet

You consume low FODMAP diet for 24 hours before taking the FODMAP challenge

Lactose Sachet

You will engage in a 4-week study to document responses to 4 Fermentable Carbohydrates(FCHOs): Lactose(25g), Fructose(25g), Sorbitol(10g), and Inulin(10g). Each FCHO, dissolved in 250ml of lukewarm water, is taken after a 24-hour low FODMAP diet to clear residual FCHOs. Exhaled H2 and CH4 are measured before and 60 minutes after the first and last meal of the low FODMAP period. Each morning, after a baseline breath test, you will consume one FCHO challenge and record breath tests for three hours at 15-minute intervals. Following each challenge, there is a 6-day washout period with your typical diet. This 24-hour low FODMAP diet, FCHO challenge, and washout cycle is repeated until all FCHOs are tested. The order of FCHO challenges is randomized and consistent among all, who remain blinded to the order to minimize confounding factors.

25g sachet having lactose roughly equal to amount of lactose present in 1 large glass of milk

Fructose Sachet

You will engage in a 4-week study to document responses to 4 Fermentable Carbohydrates(FCHOs): Lactose(25g), Fructose(25g), Sorbitol(10g), and Inulin(10g). Each FCHO, dissolved in 250ml of lukewarm water, is taken after a 24-hour low FODMAP diet to clear residual FCHOs. Exhaled H2 and CH4 are measured before and 60 minutes after the first and last meal of the low FODMAP period. Each morning, after a baseline breath test, you consume one FCHO challenge and record breath tests for three hours at 15-minute intervals. Following each challenge, there is a 6-day washout period with your typical diet. This 24-hour low FODMAP diet, FCHO challenge, and washout cycle is repeated until all FCHOs are tested. The order of FCHO challenges is randomized and consistent among all, who remain blinded to the order to minimize confounding factors.

25g sachet having fructose roughly equal to the amount of fructose present in 2 large apples

Sorbitol Sachet

You will engage in a 4-week study to document responses to 4 Fermentable Carbohydrates(FCHOs): Lactose(25g), Fructose(25g), Sorbitol(10g), and Inulin(10g). Each FCHO, dissolved in 250ml of lukewarm water, is taken after a 24-hour low FODMAP diet to clear residual FCHOs. Exhaled H2 and CH4 are measured before and 60 minutes after the first and last meal of the low FODMAP period. Each morning, after a baseline breath test, you consume one FCHO challenge and record breath tests for three hours at 15-minute intervals. Following each challenge, there is a 6-day washout period with your typical diet. This 24-hour low FODMAP diet, FCHO challenge, and washout cycle is repeated until all FCHOs are tested. The order of FCHO challenges is randomized and consistent among all, who remain blinded to the order to minimize confounding factors.

10g sachet of sorbitol is roughly equal to the amount of sorbitol present in 3 pears or 1 prune

Inulin Sachet

You will engage in a 4-week study to document responses to 4 Fermentable Carbohydrates(FCHOs): Lactose(25g), Fructose(25g), Sorbitol(10g), and Inulin(10g). Each FCHO, dissolved in 250ml of lukewarm water, is taken after a 24-hour low FODMAP diet to clear residual FCHOs. Exhaled H2 and CH4 are measured before and 60 minutes after the first and last meal of the low FODMAP period. Each morning, after a baseline breath test, you consume one FCHO challenge and record breath tests for three hours at 15-minute intervals. Following each challenge, there is a 6-day washout period with your typical diet. This 24-hour low FODMAP diet, FCHO challenge, and washout cycle is repeated until all FCHOs are tested. The order of FCHO challenges is randomized and consistent among all, who remain blinded to the order to minimize confounding factors.

A 10g sachet of inulin is roughly equal to the amount of inulin present in 1 head of garlic

AIRE-2 Portable breath analyzer

The AIRE-2 breath analyzer will capture hydrogen and methane at baseline and after every fodmap challenge

Primary outcome measure

Proof of data collection/Adherence to the protocol [ Time Frame: 40 months ]

Central Contacts and Locations

Central contacts

Anam Ahmed

9055212100 ahmea195@mcmaster.ca

Locations

McMaster University Medical Centre

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

More Information

Sponsor

McMaster University

Last update posted

Nov 25, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2024-11-25.