AIRE-2 Device for Study of Breath Analysis in IBD

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

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

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

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

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

Study 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. 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

Eligibility

Primary outcome measure(s)

• Proof of data collection/Adherence to the protocol — 40 months
  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 %.

Trial sites (1)

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