NCT07355634招募中不适用
A Randomized, Placebo-Controlled Trial Evaluating the Impact of a Synbiotic Dietary Supplement on Markers of Gastrointestinal Health
OvationLab1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- GA-Map Dysbiosis Test
研究概览
简要总结
A 12-week, randomized, double-blind, placebo-controlled clinical trial will be conducted evaluating the effectiveness of Enviromedica - Terraflora Daily Care on markers of gastrointestinal function and symptoms.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males or females age ≥ 25 years
- •Ability to read and speak English
- •Dysbiosis (≥3 on GA-Map Dysbiosis Score) on a stool test (GI360 Profile, Doctor's Data, St. Charles, Illinois)
排除标准
- •Daily use within the past month of any probiotic or prebiotic supplement
- •Current diagnosis of inflammatory bowel disease, including Crohn's or ulcerative colitis
- •Current daily usage of non-steroidal anti-inflammatory drugs (NSAID), proton pump inhibitors (PPI), or antibiotic medications
- •Current daily tobacco smoker
- •Known allergies to any substance in the study products
- •Currently pregnant or lactating women or women planning to become pregnant in the next 12 weeks
- •Current diagnosis of any other chronic health condition (e.g., cancer, chronic kidney disease) deemed clinically contraindicated for the study protocol
- •Current participation in another clinical trial
- •Participants unable to provide consent
研究组 & 干预措施
Terraflora - Daily Care
Experimental
干预措施: Synbiotic Dietary Supplement (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
GA-Map Dysbiosis Test
时间窗: 4 weeks, 12 weeks
次要结局
- Percentage of participants with dysfunction on GI360 Profile(4 weeks, 12 weeks)
- Percentage of participants with dysfunction on Thorne Gut Health Test(4 weeks, 12 weeks)
- Gastrointestinal Symptom Rating Scale(4 weeks, 12 weeks)
研究者
研究点 (1)
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