Phage-CLEAR: Phage-based Control and Limitation of Pathobionts for Microbiome Equilibrium and Resilience
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Gastrointestinal Symptom Rating Scale
研究概览
简要总结
Bacteriophages are viruses that can selectively infect specific species and strains of bacteria. Some bacterial species in the human gut have been negatively associated with gut health and skin health. This study is designed to measure the efficacy of two different bacteriophage-based treatments for 4 weeks to improve gut and skin health. These treatments are bacteriophage that target specific strains of Escherichia coli and Staphylococcus Aureus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Between 18-75 years old
- •Experiencing mild-moderate gastrointestinal distress/ abdominal pain, bloating, constipation, and/or diarrhea
排除标准
- •Younger than 18 years old or greater than 75 years old
- •BMI >29.9
- •Antibiotic use in the past 2 months
- •Use of statins, metformin, prescription NSAIDs, and MAO inhibitors, or other medications that could interfere with study outcomes, as determined by the study PI
- •Current diagnosis of cancer, liver or kidney disease, gastrointestinal diseases, or cardiometabolic disease (diabetes, cardiovascular disease)
- •Individuals with allergies to capsule ingredients
- •Pregnant or breastfeeding individuals
- •Excess alcohol consumption (≥4 drinks on any given occasion and/or ≥8 drinks/week for women, and ≥5 drinks on any given occasion and/or ≥15 drinks/week for men)
- •Use of dietary supplements that contain probiotics or phages
- •Actively trying to lose weight
- •Participation in other research studies that would interfere with study endpoints or compliance
- •Unable or unwilling to consume capsules, provide stool or blood samples, track bowel movements and symptoms, and attend scheduled clinic visits
研究组 & 干预措施
MuniPhage
1 x 10E6 Plaque Forming Units (PFU) of bacteriophage strains PBH34, CAH57, BFX121, and DNK95 that have been designed to target specific pro-inflammatory E. coli strains in the gut.
干预措施: Bacteriophages - MuniPhage (Dietary Supplement)
RenuPhage
Dietary supplement containing 1 x 10E6 PFU of phage strains LG91, BD117, CD007, and PD23 designed to target S. aureus in the gut which may also reduce S. aureus load on the skin.
干预措施: Bacteriophages - RenuPhage (Dietary Supplement)
Placebo
Rice maltodextrin
干预措施: Placebo (Other)
结局指标
主要结局
Gastrointestinal Symptom Rating Scale
时间窗: 4 weeks
The gastrointestinal symptom rating scale is a widely used tool for measuring gastrointestinal symptoms across five domains.
次要结局
未报告次要终点
研究者
Tiffany Weir
Professor
Colorado State University