BridgeMD
New treatment option for Inflammatory Bowel Diseases
Official title AIRE-2 Device for Study of Breath Analysis in IBD
ClinicalTrials.gov ID: NCT06541938
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- (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
You likely can't join if
- (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
See the full eligibility 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
- (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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.