Assessing Psyllium Given With Meals for Fructan Sensitivity in Children With Irritable Bowel Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in fecal lactate
研究概览
简要总结
The goal of this clinical trial is to learn if a fiber (psyllium) can change the way bacteria use fructans (a type of sugar) and whether psyllium can help decrease childhood irritable bowel syndrome (IBS) symptoms when eating fructans. The main questions it aims to answer are:
Aim 1: The effect of psyllium at two doses given with a fructan meal on microbial fructan fermentation (intracolonic pH; H2 gas production; gut microbiome composition; fecal short-chain fatty acids, lactate, glycomics).
Aim 2: Determine the impact of psyllium given with a fructan meal on fructan-induced GI symptoms.
Participants will first be asked to eat a specific diet over two three-day periods to determine if fructans worsen their IBS symptoms. Those with worsening symptoms with fructans will be asked to participate in the second part of the study. This includes two weeks of baseline (no change in diet) and two weeks of eating a specific diet with fructans with either psyllium or glucose. Participants will be asked to complete pain and stool diaries, submit stool specimens, swallow a pill to capture gut acid levels, and give breath samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between the ages of 12-17 years meeting pediatric Rome IV criteria for IBS
排除标准
- •Children who have had previous bowel surgery, have documented GI disorders (e.g., ulcerative colitis), or a serious chronic medical condition (e.g., diabetes)
- •weight and/or height are > or < 2 SD for age
- •have chronic conditions with GI symptoms (e.g., cystic fibrosis)
- •have been on antibiotics or probiotics within 3 months (because of potential alterations to the GI microbiome0
- •girls who are pregnant (tested with urine beta-human chorionic gonadotropin at the initial visit)
研究组 & 干预措施
Psyllium (0.5 g/year of age per day) given with fructans
Participants will receive Psyllium (0.5 g/year of age per day) given with fructans (daily dose 0.5 g/kg up to 19 grams)
干预措施: Psyllium (0.5 g/year of age per day) (Drug)
Psyllium (0.7 g/year of age per day) given with fructans
Participants will receive Psyllium (0.7 g/year of age per day) given with fructans (daily dose 0.5 g/kg up to 19 grams)
干预措施: Psyllium (0.7 g/year of age per day) (Drug)
Psyllium (0.7 g/year of age per day) given with fructans
Participants will receive Psyllium (0.7 g/year of age per day) given with fructans (daily dose 0.5 g/kg up to 19 grams)
干预措施: fructans (Other)
Psyllium (0.5 g/year of age per day) given with fructans
Participants will receive Psyllium (0.5 g/year of age per day) given with fructans (daily dose 0.5 g/kg up to 19 grams)
干预措施: fructans (Other)
Placebo (0.7 g/year of age glucose) given with fructans
Participants will receive Placebo (0.7 g/year of age glucose) given with fructans (daily dose 0.5 g/kg up to 19 grams).
干预措施: Placebo (Drug)
Placebo (0.7 g/year of age glucose) given with fructans
Participants will receive Placebo (0.7 g/year of age glucose) given with fructans (daily dose 0.5 g/kg up to 19 grams).
干预措施: fructans (Other)
结局指标
主要结局
Change in fecal lactate
时间窗: Baseline, 2 weeks
Change in fecal short-chain fatty acids
时间窗: Baseline, 2 weeks
Change in hydrogen gas production
时间窗: Baseline, 2 weeks
Change in fecal fructans
时间窗: Baseline, 2 weeks
Change in microbiome composition measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing
时间窗: Baseline, 2 weeks
次要结局
- Change in abdominal pain frequency(Baseline, 2 weeks)
- Change in abdominal pain severity(Baseline, 2 weeks)
- Change in bloating severity(Baseline, 2 weeks)
- Change in flatulence severity(Baseline, 2 weeks)
研究者
Dr Bruno Chumpitazi, M.D.
Instructor Temporary in the Department of Pediatrics, Pediatrics, Gastroenterology, Hepatology and Nutrition
Duke University