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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proof of data collection/Adherence to the protocol
研究概览
简要总结
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:
- 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.
- To assess the feasibility of using FoodMarble's FODMAP discovery kit protocol in a cohort of IBD patients and their household controls.
- 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.
- 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:
- Record regular diet in the FoodMarble app and collect baseline stool samples
- 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.
- Visit clinic to submit stool samples
详细描述
Study Design Type:
Prospective single-blinded intervention feasibility study
Methodology/Study Design:
A cohort of IBD patients and their healthy household controls will be recruited for this study. You will be instructed to use a handheld breathalyzer device, AIRE-2, to measure exhaled H2 and CH4 gas production, and its smartphone app, FoodMarble, will be used to log your diet and symptoms for a period of 5 weeks, as follows:
AIRE-2 will be used before and after two meals each day - the first meal and the last meal of the day. You will breathe into the AIRE-2 device before eating to obtain the baseline value. After the meal, you will breathe into the AIRE-2 60 minutes postprandially. The exhaled H2 and CH4 measurements will be automatically logged into the FoodMarble app, which is connected via Bluetooth. You will log your food intake and symptoms in FoodMarble. Symptoms scores will be recorded at the same time that the AIRE- 2 device is being used - 60 minutes postprandial. You will be asked not to drink alcohol during the meals that will be recorded, as this will skew the device results. You will be informed that you can consume alcoholic drinks after doing the postprandial breath test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
- •Inclusion criteria:
- •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
- •Able to provide informed consent
- •Exclusion criteria:
- •Diagnosed with IBD or other Gastrointestinal disorder
- •Use of antibiotics 1 month before enrolment
- •Pregnancy
- •Type 1 diabetes or insulin-dependent Type 2 diabetes
- •Currently being treated for eating disorder, schizophrenia, psychosis or other acute mental disorders.
研究组 & 干预措施
Case - Inflammatory Bowel Disease
Patients with IBD, under clinical remission since more than 3 months, having at least one symptom
干预措施: Inulin Sachet (Dietary Supplement)
Case - Inflammatory Bowel Disease
Patients with IBD, under clinical remission since more than 3 months, having at least one symptom
干预措施: low FODMAP diet (Dietary Supplement)
Case - Inflammatory Bowel Disease
Patients with IBD, under clinical remission since more than 3 months, having at least one symptom
干预措施: Lactose Sachet (Dietary Supplement)
Case - Inflammatory Bowel Disease
Patients with IBD, under clinical remission since more than 3 months, having at least one symptom
干预措施: Fructose Sachet (Dietary Supplement)
Case - Inflammatory Bowel Disease
Patients with IBD, under clinical remission since more than 3 months, having at least one symptom
干预措施: Sorbitol Sachet (Dietary Supplement)
Case - Inflammatory Bowel Disease
Patients with IBD, under clinical remission since more than 3 months, having at least one symptom
干预措施: AIRE-2 Portable breath analyzer (Device)
Control - Healthy household member
Family member of IBD patients who lives in the same house, shares similar diet and has no active GI disease or symptom
干预措施: Inulin Sachet (Dietary Supplement)
Control - Healthy household member
Family member of IBD patients who lives in the same house, shares similar diet and has no active GI disease or symptom
干预措施: low FODMAP diet (Dietary Supplement)
Control - Healthy household member
Family member of IBD patients who lives in the same house, shares similar diet and has no active GI disease or symptom
干预措施: Lactose Sachet (Dietary Supplement)
Control - Healthy household member
Family member of IBD patients who lives in the same house, shares similar diet and has no active GI disease or symptom
干预措施: Fructose Sachet (Dietary Supplement)
Control - Healthy household member
Family member of IBD patients who lives in the same house, shares similar diet and has no active GI disease or symptom
干预措施: Sorbitol Sachet (Dietary Supplement)
Control - Healthy household member
Family member of IBD patients who lives in the same house, shares similar diet and has no active GI disease or symptom
干预措施: AIRE-2 Portable breath analyzer (Device)
结局指标
主要结局
Proof of data collection/Adherence to the protocol
时间窗: 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 %.
次要结局
- Prevalence of positive score with symptoms between IBD and non-IBD patients(40 months)
- Microbiome taxa(40 months)
- Comparison of positive breath 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)
- Relative abundance of predicted microbial metabolic pathways(40 months)
研究者
David Armstrong
Professor
McMaster University