Comparing low FODMAP diet with Lactose Sachet for inflammatory bowel diseases
Official title: AIRE-2 Device for Study of Breath Analysis in IBD
A Feasibility Study to Use a Handheld, In-Home Breath Test Device to Measure H2 and CH4 Production from Carbohydrate Fermentation and Its Correlation with Persistent Symptoms in Inflammatory Bowel Disease Patients in Remission
- 2 groups
- One site, in Hamilton
- Recruiting
Interventions (6)
- Other intervention
low FODMAP diet
You consume low FODMAP diet for 24 hours before taking the FODMAP challenge
- Other intervention
Lactose Sachet
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
- Other intervention
Fructose Sachet
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
- Other intervention
Sorbitol Sachet
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
- Other intervention
Inulin Sachet
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
- Medical device
AIRE-2 Portable breath analyzer
The AIRE-2 breath analyzer will capture hydrogen and methane at baseline and after every fodmap challenge
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
McMaster University Medical Centre
Hamilton, Ontario
Eligibility Criteria
See who this study is looking for45 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age 18-75 years old, confirmed diagnosis of IBD (UC or CD)
- +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.
- +Age 18-75 years old, IBS-negative (Rome IV negative)
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → (IBD):
- +Use of antibiotics 1 month before enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
- +Active IBD (disease activity score, fecal calprotectin, CRP)
- +History of bowel resection
- +Presence of a stoma
- +Type 1 diabetes or insulin-dependent Type 2 diabetes
- +Currently being treated for eating disorder, schizophrenia, psychosis or other acute mental disorder
- +ControlsControl groupThe group a new treatment is measured against.Read more →: 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.
- +Inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →:
- +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
- −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.
- −Age 18-75 years old, IBS-negative (Rome IV negative)
- −Use of antibiotics 1 month before enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
- −Active IBD (disease activity score, fecal calprotectin, CRP)
- −History of bowel resection
- −Presence of a stoma
- −Type 1 diabetes or insulin-dependent Type 2 diabetes
- −Currently being treated for eating disorder, schizophrenia, psychosis or other acute mental disorder
- −ControlsControl groupThe group a new treatment is measured against.Read more →: 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.
- −Inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →:
- −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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
- −Diagnosed with IBD or other Gastrointestinal disorder
- −Use of antibiotics 1 month before enrolment
- −Type 1 diabetes or insulin-dependent Type 2 diabetes
- −Currently being treated for eating disorder, schizophrenia, psychosis or other acute mental disorders.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to detect a condition before symptoms appear.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives one or more of: low FODMAP diet, Lactose Sachet, Fructose Sachet, Sorbitol Sachet, Inulin Sachet and AIRE-2 Portable breath analyzer.
Registry label: A: Case - Inflammatory Bowel Disease
Group B, the comparison group, receives one or more of: low FODMAP diet, Lactose Sachet, Fructose Sachet, Sorbitol Sachet, Inulin Sachet and AIRE-2 Portable breath analyzer.
Registry label: B: Control - Healthy household member
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 75 years.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 60 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: 40 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Proof of data collection/Adherence to the protocolProtocolThe detailed plan a study must follow.Read more → — measured over 40 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06541938 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About low FODMAP dietDietary supplement
You consume low FODMAP diet for 24 hours before taking the FODMAP challenge
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About Lactose SachetDietary 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
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About Fructose SachetDietary 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
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About Sorbitol SachetDietary 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
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About Inulin SachetDietary 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
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About AIRE-2 Portable breath analyzerDevice
The AIRE-2 breath analyzer will capture hydrogen and methane at baseline and after every fodmap challenge
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 75 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 75 years.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 40 months.
The study as a whole is currently expected to finish around 2027-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 60 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Hamilton, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About 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
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.