Breath Analysis Device for Inflammatory Bowel Disease

(AIRE-2 Trial)

Recruiting in Palo Alto (17 mi)

Overseen by David Armstrong

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: McMaster University

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

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the AIRE-2 Device treatment for Inflammatory Bowel Disease?

Research shows that analyzing breath for certain chemicals can help distinguish between different types of bowel diseases, like Crohn's disease and ulcerative colitis, with reasonable accuracy. This suggests that breath analysis devices, like the AIRE-2, could be useful in diagnosing and monitoring these conditions. ^{1 2 3 4 5}

How is the AIRE-2 Device treatment different from other treatments for inflammatory bowel disease?

The AIRE-2 Device is unique because it uses breath analysis to help diagnose and monitor inflammatory bowel disease, offering a non-invasive alternative to traditional methods that are often invasive or less accurate. This device analyzes volatile organic compounds in the breath, which can provide insights into the disease state and help differentiate between conditions like Crohn's disease and ulcerative colitis. ^{1 2 4 5 6}

Research Team

David Armstrong

Principal Investigator

McMaster University

Eligibility Criteria

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 between 18 and 75 years old with a confirmed IBD diagnosis.

I have been in clinical remission for at least 3 months.

I am fluent in English.

Trial Timeline

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

Treatment Details

Interventions

• AIRE-2 Device (Behavioural Intervention)

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.

Participant Groups

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

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Evan Stein

McMaster University

Chief Medical Officer since 2015

MD, PhD

Sam

McMaster University

Chief Executive Officer since 2023

MBA from McMaster University

Findings from Research

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Programmed Nanoparticles for Tailoring the Detection of Inflammatory Bowel Diseases and Irritable Bowel Syndrome Disease via Breathprint. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Quantification of pentane in exhaled breath, a potential biomarker of bowel disease, using selected ion flow tube mass spectrometry. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Pulmonary functions in children with inflammatory bowel disease. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Analysis of Exhaled Breath Volatile Organic Compounds in Inflammatory Bowel Disease: A Pilot Study. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Review article: breath analysis in inflammatory bowel diseases. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Metabolomic analysis of breath volatile organic compounds reveals unique breathprints in children with inflammatory bowel disease: a pilot study. [2022]