Actively Recruiting
A Feasibility Study Using a Handheld Breath Test Device to Measure Hydrogen and Methane Production and Its Link to Symptoms in Inflammatory Bowel Disease Patients in Remission
Led by McMaster University · Updated on 2024-11-25
60
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how diet, symptoms, and gases produced by microbes in the gut relate to each other in people with inflammatory bowel disease (IBD) who have ongoing intestinal symptoms, as well as in their household members without symptoms. This prospective, single-blinded feasibility study uses a handheld breath analyzer called AIRE-2 and a smartphone app, FoodMarble, to measure and record breath hydrogen and methane levels, diet, and symptoms. The study also explores how these breath measurements relate to the gut microbiome. Participants include IBD patients in remission with persistent symptoms and their healthy household controls. Over five weeks, participants will use the AIRE-2 device to measure breath gases before and 60 minutes after their first and last meals daily. They will log food intake and symptoms in the FoodMarble app. The study includes a baseline week on a normal diet, followed by a four-week discovery period where participants follow a low FODMAP diet for 24 hours before consuming one of four fermentable carbohydrate challenges each week. Breath tests, symptom questionnaires, and stool sample collections occur regularly throughout. Participants receive training on device and app use, then record breath tests, diet, and symptoms daily. Stool samples are collected at baseline and after each carbohydrate challenge. Researchers will assess adherence to the protocol, compare breath test results and symptoms between IBD patients and controls, and analyze microbiome data. The study lasts about 40 months, with safety and feasibility monitored throughout, including participant feedback at the end.
CONDITIONS
Brief 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 diagnosis of IBD (ulcerative colitis or Crohn's disease)
- In clinical remission for at least 3 months
- Experiencing one or more IBS-like symptoms (e.g., abdominal pain, altered bowel habits, flatulence, abdominal distension)
- Own a smartphone with Bluetooth capability
- Fluent in English and able to use smartphone apps
- Able to provide informed consent
- Household controls aged 18 to 75 years, IBS-negative, asymptomatic, living with IBD patient and sharing similar diet
- Controls must also own a Bluetooth smartphone, be fluent in English, and able to provide informed consent
You will not qualify if you...
- Use of antibiotics within 1 month before enrollment
- Active IBD (based on disease activity scores, fecal calprotectin, CRP)
- History of bowel resection
- Presence of a stoma
- Pregnancy
- Type 1 diabetes or insulin-dependent type 2 diabetes
- Currently treated for eating disorder, schizophrenia, psychosis, or other acute mental disorders
- Controls with diagnosed IBD or other gastrointestinal disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) and 1 online visit for training and familiarization
Duration - 3 days
Participants are trained to use the AIRE-2 breathalyzer device and FoodMarble app and practice using them for 3 days to become comfortable before data collection begins. No data collected during this period will be used for analysis.
1 online visit for feedback on device and app use
Duration - 1 week
Participants collect breath samples, log food intake and symptoms using the device and app while consuming their typical diet. A baseline stool sample is collected at the end of this week.
Breath tests before and 60 minutes after two meals daily; 1 in-person visit for stool sample collection
Duration - 4 weeks
Participants follow a cycle of a 24-hour low FODMAP diet, consume one of four specific carbohydrate challenges, and record breath tests and symptoms for up to 3 hours post-challenge. This cycle is repeated for each carbohydrate challenge with 6-day washout periods of typical diet between challenges. Stool samples are collected after each challenge.
Breath tests before and after two meals daily; breath tests every 15 minutes for 3 hours post-challenge; multiple stool sample submissions; 4 in-person visits for stool sample drop-off
Duration - 1 day
Participants complete a feedback survey about their experience using the AIRE-2 device and FoodMarble app.
1 final survey visit
Trial Site Locations
Total: 1 location
1
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
Actively Recruiting
Research Team
A
Anam Ahmed
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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