IBD (general)Recruiting
AIRE-2 Device for Study of Breath Analysis in IBD
Not applicable · Testing low FODMAP diet, Lactose Sachet and Fructose Sachet · 1 site · McMaster University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing low FODMAP diet (a dietary supplement), Lactose Sachet (a dietary supplement), Fructose Sachet (a dietary supplement) and Sorbitol Sachet (a dietary supplement) as a screening approach. Condition(s) listed: Inflammatory Bowel Diseases.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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)
Plus 11 more requirement(s). There are also 14 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 60 participants are expected to take part.
- Start date: 2024-08-28.
- Main results expected around 2027-09-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Canada.
Main thing being measured
- Proof of data collection/Adherence to the protocol (40 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Diseases |
| Lead sponsor | McMaster University |
| Enrollment | 60 (estimated) |
| Start date | 2024-08-28 |
| Primary completion (est.) | 2027-09-30 |
| First posted | 2024-08-07 |
| Last updated | 2024-11-25 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT06541938 |
Interventions
- low FODMAP diet (Dietary Supplement)
You consume low FODMAP diet for 24 hours before taking the FODMAP challenge - Lactose Sachet (Dietary Supplement)
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… - Fructose Sachet (Dietary Supplement)
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… - Sorbitol Sachet (Dietary Supplement)
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… - Inulin Sachet (Dietary Supplement)
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… - AIRE-2 Portable breath analyzer (Device)
The AIRE-2 breath analyzer will capture hydrogen and methane at baseline and after every fodmap challenge
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| McMaster University Medical Centre | Hamilton, Ontario | Canada | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.