Effect of Trenev Trio®/Healthy Trinity® in Otherwise Healthy Adults With Recurrent Gastrointestinal Symptoms: a Double-blind, Randomized, Placebo-controlled, Parallel Group Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 9
- 主要终点
- Mean total Gastrointestinal Symptom Rating Scale (GSRS) score
研究概览
简要总结
Clinical trial to compare safety and effectiveness of 10-week supplementation with Trenev Trio®/Healthy Trinity® vs. placebo in otherwise healthy subjects with recurrent gastrointestinal symptoms.
详细描述
This study is a double-blind, randomized, placebo-controlled, parallel group trial comparing the safety and effectiveness of supplementation with Trenev Trio®/Healthy Trinity® vs. placebo in otherwise healthy subjects with recurrent gastrointestinal symptoms. Subjects will be recruited and, following successful completion of a 2-week run-in period, will be randomized to Trenev Trio®/Healthy Trinity® or placebo and will consume their assigned study product daily for 10 weeks. The study endpoints of this trial include relief of overall gastrointestinal symptoms, acid indigestion, abdominal cramping, constipation, diarrhea, gas, and bloating as well as product safety over the 10-week supplementation period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age ≥18 years
- •Body mass index between 18.5 through 39.9 kg/m2
- •At least three symptoms rated between 4 to 6 in severity (moderate to severe discomfort) on a 1 to 7 scale, one of which must be acid indigestion as determined by the "Reflux Syndrome" score
- •Self-reported "acid indigestion" symptoms (including pain/discomfort beneath the breastbone, bitter fluid in the mouth, or bloating/nausea after eating) at least 3 times per week over the previous 4 weeks
- •Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
- •Able to understand and voluntarily consent to the study and understand it's nature and purpose including potential risks, and side effects
排除标准
- •Any GSRS symptom rated a 7 in severity (very severe discomfort) on a 1 to 7 scale
- •Diagnosed gastrointestinal disease/complication or functional bowel disorder (e.g. IBS, functional constipation, IBD, ulcer, etc.) based on physical examination or documented medical history that, in the investigator's opinion, may affect subject safety or confound the evaluation of the study endpoints
- •Any non-gastrointestinal disease/complication that, in the investigator's opinion, may affect subject safety or confound the evaluation of the study endpoints
- •Regular (>3 days per week) prescription medication use for any gastrointestinal disease/condition
- •Recent (<6 months) abdominal surgery for any reason
- •Immunodeficiency
- •Recent change in anti-psychotic medication within the previous 3 months
- •Systemic steroid use within the prior month, excluding regular use of asthma medication
- •Pregnant female or breastfeeding
- •Eating disorder
- •Recent (within 2 weeks) antibiotic administration
- •History of alcohol, drug, or medication abuse
- •Daily consumption of probiotics, fermented milk, and/or yogurt
- •Known allergies to any substance in the study product
- •Participation in another study with any investigational product within 30 days of screening
结局指标
主要结局
Mean total Gastrointestinal Symptom Rating Scale (GSRS) score
时间窗: 10 weeks
Gastrointestinal Quality of Life Index (GIQLI) total score
时间窗: 10 weeks
次要结局
- Gastrointestinal Symptom Rating Scale subscores(10 weeks)
- Gas severity(10 weeks)
- Bloating severity(10 weeks)
- Acid indigestion severity(10 weeks)
- Abdominal cramping severity(10 weeks)
- Stool consistency (measured with Bristol Stool Form Scale)(10 weeks)
- Stool frequency(10 weeks)
- Concomitant medication use(10 weeks)
- Adverse event frequency(10 weeks)
- Adverse event severity(10 weeks)