Feasibility Study Using AIRE-2 Breath Device and FoodMarble App to Measure Breath Gases and Symptoms in Adults with Inflammatory Bowel Disease and Their Household Members

What this Trial Is About

Researchers are studying how diet, symptoms, and gases produced by microbes in the gut relate to each other in people with inflammatory bowel disease IBD who have ongoing intestinal symptoms, as well as in their household members without symptoms. This prospective, single-blinded feasibility study uses a handheld breath analyzer called AIRE-2 and a smartphone app, FoodMarble, to measure and record breath hydrogen and methane levels, diet, and symptoms. The study also explores how these breath measurements relate to the gut microbiome. Participants include IBD patients in remission with persistent symptoms and their healthy household controls. Over five weeks, participants will use the AIRE-2 device to measure breath gases before and 60 minutes after their first and last meals daily. They will log food intake and symptoms in the FoodMarble app. The study includes a baseline week on a normal diet, followed by a four-week discovery period where participants follow a low FODMAP diet for 24 hours before consuming one of four fermentable carbohydrate challenges each week. Breath tests, symptom questionnaires, and stool sample collections occur regularly throughout. Participants receive training on device and app use, then record breath tests, diet, and symptoms daily. Stool samples are collected at baseline and after each carbohydrate challenge. Researchers will assess adherence to the protocol, compare breath test results and symptoms between IBD patients and controls, and analyze microbiome data. The study lasts about 40 months, with safety and feasibility monitored throughout, including participant feedback at the end.

AIRE-2 Device for Study of Breath Analysis in IBD