Breath Analysis Device for Inflammatory Bowel Disease

(AIRE-2 Trial)

Overseen By Anam Ahmed

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Active IBD, Bowel resection, Pregnancy, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device and app combination to examine how diet affects symptoms in individuals with inflammatory bowel disease (IBD), such as Crohn's disease or ulcerative colitis. Participants will use the AIRE-2 device (also known as the FoodMarble AIRE 2) to measure gases in their breath and the FoodMarble app to track their diet and symptoms. The goal is to identify links between certain foods and symptoms like stomach pain or bloating. Ideal candidates include those in IBD remission (feeling better for 3+ months) but still experiencing symptoms, along with their healthy household members who share the same diet. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on diet and IBD symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude participants who have used antibiotics in the month before enrollment.

What prior data suggests that the AIRE-2 device is safe for use in IBD patients?

Research shows that the AIRE-2 device is generally safe for use. In earlier studies, researchers used this tool to measure gases like hydrogen and methane in individuals with digestive issues. These studies did not report any serious side effects. The device is easy to use and helps identify food intolerances by tracking gases in the breath.

Although the AIRE-2 device is not a treatment, it gathers information about conditions like inflammatory bowel disease (IBD). Most users find it comfortable, and it rarely causes any problems. It functions like a personal breath tester to observe how the body responds to different foods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The AIRE-2 device is unique because it offers a non-invasive way to monitor and potentially manage inflammatory bowel disease (IBD) by analyzing breath samples. Unlike standard treatments for IBD, which often involve medication or invasive procedures, this device seeks to identify disease activity through biomarkers in exhaled breath. Researchers are excited because this method could lead to earlier detection of flares and better management of symptoms, providing a more convenient and less intrusive option for patients. Additionally, it could offer insights into the dietary and environmental factors impacting IBD, thanks to its use in both patients and their healthy household members.

What evidence suggests that the AIRE-2 device is effective for analyzing diet and symptoms in IBD patients?

Research shows that the AIRE-2 device effectively tracks gases in the breath, such as hydrogen and methane, which are linked to gut problems. This device aids in diagnosing conditions like SIBO (small intestinal bacterial overgrowth) by analyzing breath samples. By measuring these gases, it provides insights into how diet affects gut symptoms and intestinal activity. In this trial, researchers will use the AIRE-2 device to monitor patients with IBD (inflammatory bowel disease) to assess how different foods impact their symptoms. Overall, the AIRE-2 device may offer a new method to monitor and potentially manage gut health in IBD patients. ^{1 3 4 6 7}

Who Is on the Research Team?

David Armstrong

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with confirmed IBD in remission for at least 3 months, experiencing IBS-like symptoms. Participants must own a smartphone with Bluetooth and be fluent in English to use the app and provide consent.

Inclusion Criteria

I am fluent in English.

I can follow instructions to use smartphone apps.

I can understand and agree to the study's procedures and risks.

Timeline for a Trial Participant

Screening and Familiarization

Participants are screened for eligibility to participate in the trial and familiarized with the AIRE-2 device and FoodMarble app

1 week

2 visits (1 in-person, 1 virtual)

Baseline

Participants record regular diet and collect baseline stool samples while using the AIRE-2 device and FoodMarble app

1 week

1 visit (in-person)

Discovery

Participants undergo FODMAP challenges with Lactose, Fructose, Sorbitol, and Inulin, recording breath levels, symptoms, and stool samples

4 weeks

4 visits (in-person)

Follow-up

Participants complete a feedback survey and final assessments

1 week

What Are the Treatments Tested in This Trial?

Interventions

• AIRE-2 Device

Trial Overview The study tests if the AIRE-2 breath analyzer and FoodMarble app can track diet, symptoms, and breath hydrogen/methane levels in IBD patients versus their household controls. It involves a low FODMAP diet followed by specific sugar challenges over four weeks.

How Is the Trial Designed?

Group I: Case - Inflammatory Bowel Disease Experimental Treatment 6 Interventions

Patients with IBD, under clinical remission since more than 3 months, having at least one symptom

Group II: Control - Healthy household member Active Control 6 Interventions

Family member of IBD patients who lives in the same house, shares similar diet and has no active GI disease or symptom

AIRE-2 Device is already approved in European Union, United States for the following indications:

Approved in European Union as FoodMarble AIRE 2 for:

• Small Intestinal Bacterial Overgrowth (SIBO) diagnosis
• FODMAP intolerance testing

Approved in United States as FoodMarble AIRE 2 for:

• Small Intestinal Bacterial Overgrowth (SIBO) diagnosis
• FODMAP intolerance testing

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

Programmable molecularly modified gold nanoparticles can effectively differentiate between the breathprints of irritable bowel syndrome (IBS) and inflammatory bowel diseases (IBD) with an accuracy of 81%.

The sensors also show a 75% accuracy in distinguishing between Crohn's disease and ulcerative colitis, indicating their potential for clinical applications in diagnosing these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed Nanoparticles for Tailoring the Detection of Inflammatory Bowel Diseases and Irritable Bowel Syndrome Disease via Breathprint. Karban, A., Nakhleh, MK., Cancilla, JC., et al.[2018]

A new method using selected ion flow tube mass spectrometry (SIFT-MS) can accurately quantify pentane levels in human breath, which may help diagnose inflammatory bowel diseases like Crohn's disease and ulcerative colitis non-invasively.

In a pilot study, pentane levels were significantly higher in patients with Crohn's disease (114 ppbv) and ulcerative colitis (84 ppbv) compared to healthy controls (40 ppbv), suggesting that breath analysis could be a useful tool for monitoring these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantification of pentane in exhaled breath, a potential biomarker of bowel disease, using selected ion flow tube mass spectrometry. Dryahina, K., Španěl, P., Pospíšilová, V., et al.[2019]

Breath analysis can potentially differentiate inflammatory bowel disease (IBD) from healthy individuals by measuring specific volatile organic compounds, with a panel of three compounds showing a high accuracy (AUC 0.96) in distinguishing pediatric IBD cases.

While breath analysis shows promise for monitoring disease activity in IBD patients, it is not yet ready for routine clinical use, indicating a need for further research to refine detection techniques and establish clear diagnostic patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review article: breath analysis in inflammatory bowel diseases. Kurada, S., Alkhouri, N., Fiocchi, C., et al.[2018]

A study involving 117 participants (62 with inflammatory bowel disease (IBD) and 55 healthy controls) found that specific volatile organic compounds (VOCs) in exhaled breath can effectively differentiate between pediatric patients with IBD and healthy individuals, achieving a high accuracy with an area under the curve (AUC) of 0.96.

Three specific VOCs (1-octene, 1-decene, and (E)-2-nonene) were identified as strong predictors of IBD, suggesting that breath testing could serve as a non-invasive diagnostic tool for identifying children who may need further endoscopic evaluation for IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolomic analysis of breath volatile organic compounds reveals unique breathprints in children with inflammatory bowel disease: a pilot study. Patel, N., Alkhouri, N., Eng, K., et al.[2022]

In children with Crohn's disease (CD) and ulcerative colitis (UC), fractional exhaled nitric oxide (FeNO) levels are significantly higher compared to healthy controls, indicating airway inflammation associated with these inflammatory bowel diseases.

However, elevated FeNO levels do not correlate with the activity of the intestinal disease, suggesting that while there may be pulmonary involvement, it does not directly reflect the severity of the gastrointestinal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary functions in children with inflammatory bowel disease. Gut, G., Ben-Tov, A., Lahad, A., et al.[2017]

A pilot study involving 56 individuals (20 with ulcerative colitis, 18 with Crohn's disease, and 18 healthy controls) demonstrated that breath analysis using selected ion flow tube mass spectrometry (SIFT-MS) can effectively distinguish between inflammatory bowel diseases and healthy individuals based on volatile organic compounds (VOCs).

The study found that specific VOCs, such as dimethyl sulphide and hydrogen sulphide, allowed for accurate differentiation between Crohn's disease and ulcerative colitis, achieving high sensitivity and specificity, with area under the curve values of 0.86 for CD vs healthy controls and 0.83 for CD vs UC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Exhaled Breath Volatile Organic Compounds in Inflammatory Bowel Disease: A Pilot Study. Hicks, LC., Huang, J., Kumar, S., et al.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06541938

AIRE-2 Device for Study of Breath Analysis in IBD The goal of this Prospective single-blinded intervention feasibility study is the utilization of the AIRE-2 device and FoodMarble app to elucidate the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11602852/

Validation of a Hand-Held Point-of-Care Device to Measure ... This study aimed to evaluate the utility of a portable, point-of-care breath analysis device (AIRE®, FoodMarble) in patients suspected to have SIBO.

3. withpower.com withpower.com/trial/phase-inflammatory-bowel-diseases-7-2024-d3db4

Breath Analysis Device for Inflammatory Bowel Disease The study tests if the AIRE-2 breath analyzer and FoodMarble app can track diet, symptoms, and breath hydrogen/methane levels in IBD patients versus their ...

4. medrxiv.org medrxiv.org/content/10.1101/2022.04.21.22274143v1.full-text

Improving the Diagnosis of SIBO Using an At-Home ... These data support the use of the AIRE device as a viable alternative to mail-in LHBT kits for the “standard” diagnosis of SIBO based on breath ...

5. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/557922

AIRE-2 Device for Study of Breath Analysis in IBD The goal of this Prospective single-blinded intervention feasibility study is the utilization of the AIRE-2 device and FoodMarble app to ...

6. foodmarble.com foodmarble.com/store/foodmarble-aire-2?srsltid=AfmBOorUVq-StOSwE0d5EZa1--VN8mloU2srAZVI2s-x55aPZUjGNQNL

FoodMarble AIRE 2 | No.1 Methane and Hydrogen Breath ... Your personal digestive breath tester that helps you identify food intolerances and improve gut health. $ 299. Free Shipping. Buy now.

7. foodmarble.com foodmarble.com/store/?srsltid=AfmBOoogeI3OKFf74ANkgHHas9bOUkrLtJXUOmmgtkUHnBI-egM-9WAF

Store - Our Products | FoodMarble “I would absolutely recommend the AIRE 2 to people with IBS, SIBO or IMO. It's a tool that helps you learn what's working for your digestion, ultimately ...