NCT07720362尚未招募不适用
Open-Label Clinical Trial Evaluating the Impact of a Multi-Strain Commensal Probiotic Dietary Supplement on Gastrointestinal Microbiota Composition, Functional Gastrointestinal Markers, and Gastrointestinal Symptoms
OvationLab1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年7月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Relative Abundance of Commensal Microorganisms
研究概览
简要总结
A single-arm, open-label prospective study will be conducted evaluating the impact of 8 weeks of supplementation at the manufacturer-recommended dose of Complete Commensal Probiotic™ on the GI-MAP stool test panel (Diagnostic Solutions Laboratory, Alpharetta, GA), gastrointestinal symptoms, digestion-associated quality of life. and overall physical health, mental health, and anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult females or males age ≥ 18 years
- •At least moderate gastrointestinal distress, defined as a score of ≥ 4 on any domain of the Gastrointestinal Symptoms Rating Scale (GSRS) at screening
- •Ability to read and speak English
- •Ability and willingness to collect an at-home stool sample for GI-MAP testing
排除标准
- •Current or recent (within the prior 90 days) use of a probiotic dietary supplement
- •Current or recent (within the prior 90 days) use of systemic antibiotics, antifungals, or antiparasitic medications
- •Known allergies to any ingredients in the product
- •Currently pregnant or lactating women or women planning to become pregnant in the next 8 weeks
- •Current diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis), celiac disease, active gastrointestinal malignancy, or other chronic health condition (e.g., cancer, heart failure, history of pancreatitis, type I or II diabetics on insulin) deemed clinically contraindicated for the study protocol
- •Severely immunocompromised status (e.g., active chemotherapy, post-transplant immunosuppression, advanced HIV)
- •Participants unable to provide consent
研究组 & 干预措施
Complete Commensal Probiotic
Experimental
干预措施: Complete Commensal Probiotic (Dietary Supplement)
结局指标
主要结局
Relative Abundance of Commensal Microorganisms
时间窗: Baseline and end of 8-week intervention
Counts of microbes per gram of each organism on GI-MAP test
次要结局
- Functional and Microbial Markers of Intestinal Health(Baseline and end of 8-week intervention)
- Gastrointestinal Symptoms Rating Scale(Baseline and end of 8-week intervention)
- Digestion-Associated Quality of Life Questionnaire(Assessed at baseline and end of 8-week study.)
- PROMIS - Global Health(Baseline and end of 8-week study.)
- PROMIS - Anxiety Short Form 8a(Assessed at baseline and end of 8-week study.)
研究者
研究点 (1)
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