The Effect of Gastric Acid Suppression on Probiotic Colonization
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Relative Abundance of VSL#3 Probiotic Bacterial Strains When Ingested in the Presence or Absence of the Proton Pump Inhibitor (PPI) Omeprazole at Week 4.
研究概览
简要总结
Probiotics are over-the-counter dietary products with microorganisms that are generally consumed for health benefit. However, the durability of these microorganisms is unclear, particularly when they pass through the highly acidic environment of the stomach. We will test the colonization of these microorganisms among individuals who consume probiotics with and without acid suppression therapy.
详细描述
All activities will be related to research. Participants will be randomized to receive either over-the-counter acid suppression medication or placebo from weeks -2 through week 4. All participants will receive VSL #3 (over-the-counter probiotic) from weeks 0 through 4. Survey data, serum, and stool samples will be collected at weeks -2, 0, and 4.
The intervention medication and probiotics have a very low side effect profile and are available over the counter. All data collection methods are non-invasive.
Elucidation of the effects of acid suppression on probiotic colonization will allow us to better understand the utility of probiotics use by individuals on acid suppression medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy volunteers ages 18 years and ≤ 75 years.
- •Able to visit the study Doctor's office 3 times, answer 3 questionnaires, and provide stools and blood samples.
排除标准
- •Gastric cancer, Barrett's esophagus cancer, any gastrointestinal condition, or soy or gluten sensitivity
- •Previous abdominal surgery
- •Currently pregnant or nursing
- •Had H. Pylori Infection
- •Diagnosed with any chronic medical condition other than hypertension or hyperlipidemia
- •Currently consuming herbs or probiotics
研究组 & 干预措施
Omeprazole and VSL #3
Participants will receive a proton pump inhibitor (Omeprazole) and VSL #3 Probiotics
干预措施: Omeprazole (Drug)
Omeprazole and VSL #3
Participants will receive a proton pump inhibitor (Omeprazole) and VSL #3 Probiotics
干预措施: VSL #3 (Dietary Supplement)
Placebo and VSL #3
Participants will receive placebo and VSL #3 Probiotics
干预措施: VSL #3 (Dietary Supplement)
Placebo and VSL #3
Participants will receive placebo and VSL #3 Probiotics
干预措施: Placebo (Drug)
结局指标
主要结局
Relative Abundance of VSL#3 Probiotic Bacterial Strains When Ingested in the Presence or Absence of the Proton Pump Inhibitor (PPI) Omeprazole at Week 4.
时间窗: Week 4
Relative abundance is reported as the percent of combined VSL #3 probiotic bacteria strains in the bacteria sample (S. thermophiles, B. breve, B. longum, B. infantis, L. acidophilus, L. plantarum, L. paracasei, L. delbrueckii subsp. bulgaricus) following their ingestion in the presence or absence of the gastric acid suppression drug omeprazole. Stool samples were assessed.
次要结局
- Number of Participants With Symptoms Related to VSL#3 Treatment.(Week 0 through Week 4)
- Change in Peak Intensity of Metabolites of Interest Before and After VSL#3 Probiotic Administration (Placebo and VSL#3 Group).(Week 0 and Week 4)
- Change in Peak Intensity of the Metabolite 1H-Indole-4-carbaldehyde Before and After VSL#3 Probiotic Administration (Omeprazole and VSL #3).(Week 0 and Week 4)
- Relative Abundance (Mean Value) of Most Abundant Bacterial Phylum Before and After VSL#3 Probiotic Administration(Week 0 and Week 4)
研究者
Aida Habtezion
Associate Professor of Medicine (Gastroenterology and Hepatology)
Stanford University