Intestinal Microbiome Fructan Metabolism and Symptom Generation in Childhood IBS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 4
- 主要终点
- Operational Taxonomic Units (microbiome composition derived from 16s rRNA sequencing)
研究概览
简要总结
This study evaluates whether the gut microbiome is involved in determining whether children with irritable bowel syndrome (IBS) develop worsening GI symptoms (e.g. pain) when given fructans (a sugar often found in wheat). Participants will both receive a diet with fructans and a diet without fructans.
详细描述
Fructans (fructo-oligosaccharides) are a type of carbohydrate which can not be hydrolyzed by humans. It is commonly found in wheat in the American diet. After ingestion they arrive essentially intact into the colon where they are metabolized by the colonic microbiome. Fructan avoidance has been found to help decrease gastrointestinal symptoms (e.g. pain) in those with IBS.
However not all individuals with IBS have worsening symptoms when eating fructans in their diet. This study seeks to evaluate whether the microbiome is involved in determining whether an individual with IBS has worsening symptoms with fructan ingestion.
Following a one week baseline period, participants will be randomized in a double-blind cross-over fashion to either a 72 hour meal period with fructans or a 72 hour meal period with maltodextrin (placebo). A washout period of at least 10 days will occur in between. Symptoms will be captured using a stool and pain diary. Stool specimens and urine specimens will be obtained at baseline and during the dietary interventions. Breath hydrogen testing will be obtained during the dietary interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children ages 7-17 years
- •Children with IBS will meet Rome III criteria per the Rome III questionnaire
- •Healthy children will not have chronic conditions
- •English speaking and able to read/write in English
排除标准
- •Previous bowel surgery
- •Documented gastrointestinal disorder (e.g. ulcerative colitis)
- •Serious chronic medical condition (e.g. diabetes)
- •Weight and/or height are greater than or less than 2 standard deviations for age
- •Chronic conditions with GI symptoms (e.g. cystic fibrosis)
- •Antibiotics within the past 3 months
- •Pregnancy
- •Autism spectrum disorder and/or significant developmental delay
- •Mood disorders (e.g. major depression)
- •Known post-infectious etiology
结局指标
主要结局
Operational Taxonomic Units (microbiome composition derived from 16s rRNA sequencing)
时间窗: Three days
Children with IBS who have worsening GI symptoms with fructans vs. those who do not
Microbiome metabolic signatures related to fructan metabolism
时间窗: Three days
Children with IBS who have worsening GI symptoms with fructans vs. those who do not
Metabolic products of fructan metabolism
时间窗: Three days
In those with IBS who have worsening symptoms when given fructans, the investigators will correlate fructan metabolic byproducts with GI symptoms (e.g. pain)
次要结局
- Breath hydrogen and methane production symptoms(Three days)
- Microbiome related signatures(Three days)
- Overall metabolic products(Three days)
- Overall microbiome metabolic signatures(Three days)
研究者
Bruno Chumpitazi
Assistant Professor
Baylor College of Medicine