Exploratory Study of the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Observed Operational Taxonomic Unit (OTU) diversity.
研究概览
简要总结
The purpose of this study is to investigate the impact of the probiotic Lactobacillus rhamnosus (LGG) on proton pump inhibitor (PPI)-induced changes to the microbes that live in the gastrointestinal tract and are passed out in the stool. PPI medicines reduce stomach acid and are commonly used to treat acid reflux disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals on an unrestricted regular diet with no dietary restrictions (vegan, low FODMAP, gluten free, dairy-free etc) or other fad diets (e.g., keto, intermittent fasting, etc.).
- •Healthy subjects will be screened for current or chronic GI symptoms using a 16-item questionnaire.
- •Only those with an absence of symptoms will eligible to participate.
排除标准
- •For healthy volunteers, will include prior surgery altering the esophagus, stomach, and intestine (except appendectomy).
- •Chronic daily use of medications affecting GI secretion or motor function.
- •The presence of any GI-motility affecting systemic diseases or untreated psychiatric disease.
- •Pregnancy.
研究组 & 干预措施
Lactobacillus rhamnosus GG Group
Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive Lactobacillus rhamnosus GG two capsules daily taken with a meal.
干预措施: Omeprazole (Drug)
Lactobacillus rhamnosus GG Group
Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive Lactobacillus rhamnosus GG two capsules daily taken with a meal.
干预措施: Lactobacillus rhamnosus GG (Dietary Supplement)
Placebo Group
Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive placebo two capsules daily taken with a meal.
干预措施: Omeprazole (Drug)
Placebo Group
Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive placebo two capsules daily taken with a meal.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Observed Operational Taxonomic Unit (OTU) diversity.
时间窗: Baseline, Day 56
Observed OTU counts in each stool sample will be tested at varying cutoffs by determining the number of OTUs per sample.
次要结局
- Changes in Shannon diversity index.(Baseline, Day 56)
- Changes in enrichment according to Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways.(Baseline, Day 56)
- Adverse Events(60 days)
- Changes in taxa units.(Baseline, Day 56)
研究者
John K. DiBaise
Principal Investigator
Mayo Clinic