AIRE-2 Device for Study of Breath Analysis in IBD

NCT06541938 | Recruiting

• 1 other identifier: 17342
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.To assess the feasibility of using FoodMarble's FODMAP discovery kit protocol in a cohort of IBD patients and their household controls.
3. 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. 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.
5. 5.Record regular diet in the FoodMarble app and collect baseline stool samples
6. 6.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.
7. 7.Visit clinic to submit stool samples

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Proof of data collection/Adherence to the protocol

  For each data set, we will divide the number of logged data divided by the total data expected to be logged. For example, the number of breath tests using AIRE-2 logged by the participant / total expected. This will also apply to the diet log. The results will be expressed in %.

  40 months

Secondary Outcomes (6)

• Comparison of positive breath between IBD and non-IBD patients

  40 months

• Prevalence of positive score with symptoms between IBD and non-IBD patients

  40 months

• Correlation of positive breath tests with severity of symptoms

  40 months

• Correlation of breath scores with food reported as being intolerant by the patients

  40 months

• Microbiome taxa

  40 months

Study Arms (2)

Case - Inflammatory Bowel Disease

EXPERIMENTAL

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

Dietary Supplement: low FODMAP diet; Dietary Supplement: Lactose Sachet; Dietary Supplement: Fructose Sachet; Dietary Supplement: Sorbitol Sachet; Dietary Supplement: Inulin Sachet; Device: AIRE-2 Portable breath analyzer

Control - Healthy household member

ACTIVE COMPARATOR

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

Dietary Supplement: low FODMAP diet; Dietary Supplement: Lactose Sachet; Dietary Supplement: Fructose Sachet; Dietary Supplement: Sorbitol Sachet; Dietary Supplement: Inulin Sachet; Device: AIRE-2 Portable breath analyzer

Interventions

low FODMAP diet DIETARY_SUPPLEMENT

You consume low FODMAP diet for 24 hours before taking the FODMAP challenge

Case - Inflammatory Bowel Disease; Control - Healthy household member

Lactose Sachet DIETARY_SUPPLEMENT

You will engage in a 4-week study to document responses to 4 Fermentable Carbohydrates(FCHOs): Lactose(25g), Fructose(25g), Sorbitol(10g), and Inulin(10g). Each FCHO, dissolved in 250ml of lukewarm water, is taken after a 24-hour low FODMAP diet to clear residual FCHOs. Exhaled H2 and CH4 are measured before and 60 minutes after the first and last meal of the low FODMAP period. Each morning, after a baseline breath test, you will consume one FCHO challenge and record breath tests for three hours at 15-minute intervals. Following each challenge, there is a 6-day washout period with your typical diet. This 24-hour low FODMAP diet, FCHO challenge, and washout cycle is repeated until all FCHOs are tested. The order of FCHO challenges is randomized and consistent among all, who remain blinded to the order to minimize confounding factors. 25g sachet having lactose roughly equal to amount of lactose present in 1 large glass of milk

Case - Inflammatory Bowel Disease; Control - Healthy household member

Fructose Sachet DIETARY_SUPPLEMENT

You will engage in a 4-week study to document responses to 4 Fermentable Carbohydrates(FCHOs): Lactose(25g), Fructose(25g), Sorbitol(10g), and Inulin(10g). Each FCHO, dissolved in 250ml of lukewarm water, is taken after a 24-hour low FODMAP diet to clear residual FCHOs. Exhaled H2 and CH4 are measured before and 60 minutes after the first and last meal of the low FODMAP period. Each morning, after a baseline breath test, you consume one FCHO challenge and record breath tests for three hours at 15-minute intervals. Following each challenge, there is a 6-day washout period with your typical diet. This 24-hour low FODMAP diet, FCHO challenge, and washout cycle is repeated until all FCHOs are tested. The order of FCHO challenges is randomized and consistent among all, who remain blinded to the order to minimize confounding factors. 25g sachet having fructose roughly equal to the amount of fructose present in 2 large apples

Case - Inflammatory Bowel Disease; Control - Healthy household member

Sorbitol Sachet DIETARY_SUPPLEMENT

You will engage in a 4-week study to document responses to 4 Fermentable Carbohydrates(FCHOs): Lactose(25g), Fructose(25g), Sorbitol(10g), and Inulin(10g). Each FCHO, dissolved in 250ml of lukewarm water, is taken after a 24-hour low FODMAP diet to clear residual FCHOs. Exhaled H2 and CH4 are measured before and 60 minutes after the first and last meal of the low FODMAP period. Each morning, after a baseline breath test, you consume one FCHO challenge and record breath tests for three hours at 15-minute intervals. Following each challenge, there is a 6-day washout period with your typical diet. This 24-hour low FODMAP diet, FCHO challenge, and washout cycle is repeated until all FCHOs are tested. The order of FCHO challenges is randomized and consistent among all, who remain blinded to the order to minimize confounding factors. 10g sachet of sorbitol is roughly equal to the amount of sorbitol present in 3 pears or 1 prune

Case - Inflammatory Bowel Disease; Control - Healthy household member

Inulin Sachet DIETARY_SUPPLEMENT

You will engage in a 4-week study to document responses to 4 Fermentable Carbohydrates(FCHOs): Lactose(25g), Fructose(25g), Sorbitol(10g), and Inulin(10g). Each FCHO, dissolved in 250ml of lukewarm water, is taken after a 24-hour low FODMAP diet to clear residual FCHOs. Exhaled H2 and CH4 are measured before and 60 minutes after the first and last meal of the low FODMAP period. Each morning, after a baseline breath test, you consume one FCHO challenge and record breath tests for three hours at 15-minute intervals. Following each challenge, there is a 6-day washout period with your typical diet. This 24-hour low FODMAP diet, FCHO challenge, and washout cycle is repeated until all FCHOs are tested. The order of FCHO challenges is randomized and consistent among all, who remain blinded to the order to minimize confounding factors. A 10g sachet of inulin is roughly equal to the amount of inulin present in 1 head of garlic

Case - Inflammatory Bowel Disease; Control - Healthy household member

AIRE-2 Portable breath analyzer DEVICE

The AIRE-2 breath analyzer will capture hydrogen and methane at baseline and after every fodmap challenge

Case - Inflammatory Bowel Disease; Control - Healthy household member

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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, will be recruited at the Digestive Diseases Clinic, McMaster University, Hamilton, Ontario.
• Controls: A total of 30 non-IBD volunteers from the same household as the recruited IBD patients who do not have any IBS-like symptom will be recruited as controls.
• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University Medical Centre

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• David Armstrong

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anam Ahmed

CONTACT

9055212100; ahmea195@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: We have 2 groups (IBD patients \& healthy controls) so 30 per group

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: August 7, 2024
• Study Start: August 28, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

CA (1)