Actively Recruiting
AIRE-2 Device for Study of Breath Analysis in IBD
Led by McMaster University · Updated on 2024-11-25
60
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
AIRE-2 Device for Study of Breath Analysis in IBD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old with confirmed IBD diagnosis (ulcerative colitis or Crohn's disease)
- In clinical remission from IBD for at least 3 months
- Experience one or more IBS-like symptoms (abdominal pain, altered bowel habits, flatulence, bloating, etc.)
- Own a smartphone with Bluetooth capability
- Fluent in English and able to use smartphone apps
- Able to provide informed consent
- For controls: age 18 to 75 years old, IBS-negative, living in the same household as an IBD patient, asymptomatic
You will not qualify if you...
- Use of antibiotics within 1 month before enrollment
- Active IBD disease (based on disease activity scores, fecal calprotectin, CRP)
- History of bowel resection or 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 disorders
- For controls: diagnosed with IBD or other gastrointestinal disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
Actively Recruiting
Research Team
A
Anam Ahmed
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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