RecruitingNAINTERVENTIONAL

AIRE-2 Device for Study of Breath Analysis in IBD

This research wants to understand the connection between what you eat, your gut bacteria, and your symptoms if you have Inflammatory Bowel Disease (IBD). It's also looking at healthy people living in the same home. The study uses a small, portable breath device called AIRE-2, together with a smartphone app called FoodMarble. This device measures certain gases in your breath, while the app helps you record your food intake and any symptoms you have. The main goals are to see if these tools are easy to use for people with IBD and their families, to gather early information on how diet, symptoms and breath gases are related, and to explore if these relate to the types of bacteria found in your gut. It hopes to shed light on why some people with IBD continue to have gut issues.

At a glance

Status

Recruiting

Phase

Sponsor

McMaster University

Enrolment target

Start

28 Aug 2024

Estimated completion

31 Dec 2027

Inflammatory Bowel Diseases

What is this study about?

This study is designed to help us better understand why people with Inflammatory Bowel Disease (IBD), like Crohn's disease or ulcerative colitis, sometimes continue to experience gut symptoms even when their IBD is otherwise under control. We also want to compare these findings with healthy members of their families.

The research focuses on how certain foods, particularly a group called FODMAPs, interact with the microscopic bugs living in your gut. When these gut bugs break down food, they produce gases like hydrogen and methane. By measuring these gases in your breath using a special small device called AIRE-2, and recording your diet and symptoms with a smartphone app, we hope to build a clearer picture of these complex relationships. This could one day lead to more personalised advice for managing IBD symptoms.

Ultimately, this study aims to see if the AIRE-2 device and FoodMarble app are useful tools for people to monitor their health, and to gather important early information about how diet, symptoms, and the gases produced in your gut are all linked. We are also looking into how these breath gases and symptoms might connect to the unique mix of bacteria in your gut.

Key takeaways

Study examines how diet, gut bugs, and symptoms link in IBD.
Uses a hand-held device (AIRE-2) and a smartphone app (FoodMarble).
Involves tracking food, symptoms, and breath gases for 5 weeks.
Includes weekly short low-FODMAP diets followed by food challenges.
Aims to understand persistent gut symptoms in IBD patients.
Recruiting both IBD patients and healthy household members.

Who may be eligible?

This study is looking for two main groups of people: adults aged 18 to 75 who have Inflammatory Bowel Disease (IBD) and a healthy family member living in the same home.

For those with IBD, you need to have a confirmed diagnosis of ulcerative colitis or Crohn's disease and currently be in a period where your disease is inactive (in remission) for at least three months. However, you should still be experiencing some regular gut symptoms like tummy pain, changes in bowel habits, or bloating. You also need to own a smartphone with Bluetooth and be able to understand instructions in English.

There are certain reasons you couldn't join, such as having taken antibiotics in the last month, having very active IBD, a history of bowel surgery or a stoma, being pregnant, or having certain types of diabetes or mental health conditions. For healthy household members, you should also be 18-75, living with an IBD participant, not have any tummy symptoms like IBS, and meet similar smartphone and language requirements. You also shouldn't have IBD or any other major gut condition, be pregnant, or have the specific diabetes or mental health conditions listed.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Do you have a diagnosis of Crohn's disease or ulcerative colitis?
Is your IBD currently quiet (in remission) but you still have tummy symptoms?
Do you own a smartphone with Bluetooth capacity?
Have you avoided antibiotics in the last month?
Are you able to provide stool samples?

Answer every question to see your result.

What does participation involve?

If you join this study, you will use a small, portable breath testing device called AIRE-2, which we will provide, along with a smartphone app called FoodMarble. You'll be shown how to use both.

For 5 weeks, you will regularly use the AIRE-2 device to measure gases in your breath before and after your first and last meals each day. You'll also use the FoodMarble app to record what you eat and any symptoms you experience. For four of these weeks, you will follow a special 'low FODMAP' diet for 24 hours each week. After this diet, you will take special sachets (one each week) containing different types of sugars (Lactose, Fructose, Sorbitol, Inulin) and continue breath testing and symptom recording. You will also need to provide stool (poo) samples, both at the start and during the study. There will be at least one visit to the clinic to submit these stool samples. The total study period is 5 weeks.

Potential risks and benefits

Taking part in this study may offer a better understanding of your own body's reactions to food and how it relates to your symptoms, though we cannot guarantee direct health benefits. You will receive free access to the AIRE-2 device and FoodMarble app, which could help you learn more about your diet. There are no major physical risks associated with breath testing or diet recording. You might find the low FODMAP diet and managing recordings a bit time-consuming, and providing stool samples can be inconvenient. Your medical information will be kept private. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

McMaster University Medical Centre
Verified postcode
Hamilton, Canada· Recruiting

Common questions

What is IBD?

IBD stands for Inflammatory Bowel Disease, which is a group of conditions that cause long-term inflammation in your gut, such as Crohn's disease and ulcerative colitis.

What are FODMAPs?

FODMAPs are types of carbohydrates (sugars) found in certain foods that can cause digestive issues in some people when fermented by gut bacteria.

What does the AIRE-2 device do?

The AIRE-2 is a small device you breathe into to measure specific gases (hydrogen and methane) in your breath, which can indicate how your gut is breaking down food.

How long will I be in the study?

Your participation in the study involving the breath device, app, and diet changes will last for a total of five weeks.

Will I get to keep the AIRE-2 device?

The study provides the AIRE-2 device for your use during the study period. Information about keeping it afterwards isn't specified, but it's generally returned unless stated otherwise.

How to find out more

Anam Ahmed

ahmea195@mcmaster.ca 9055212100 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.