A Clinical Trial to Assess the Effect of a Combined Pre-, Pro-, and Post-biotic Supplement on Gut and Metabolic Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in participant-reported gastrointestinal symptoms [Time Frame: Baseline to 4 weeks]
研究概览
简要总结
This is a virtual, single-arm clinical trial that will last 4-weeks. Participants will take the supplement daily and complete questionnaires at baseline, week 2, and week 4. Participants will provide photos of their face and stomach at baseline and week 4.
Gut health and associated health outcomes, including brain, skin, and immune function, will be evaluated at baseline and at each check-in. Likert scale responses will be statistically compared from baseline to each check-in. Participant responses on product feedback will be presented as % scores. Baseline and endline photos from each study part will be provided by participants.
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
- 是
入选标准
- •Men or women
- •18 years of age or older
- •Experience at least one of the following symptoms: regular bloating/gas, irregular bowel movements, heartburn, or poor digestive health
- •Generally healthy
排除标准
- •Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- •Allergic to bees, bee products, poplar tree products, or balsam of Peru
- •Anyone with known severe allergic reactions.
- •Women who are pregnant, breastfeeding or attempting to become pregnant
- •Unwilling to follow the study protocol.
- •Has introduced any new forms of medication or supplements targeting gut health within the last 3 months
- •Has taken antibiotics in the last 3 months
结局指标
主要结局
Change in participant-reported gastrointestinal symptoms [Time Frame: Baseline to 4 weeks]
时间窗: 4 weeks
Assessed via study-specific questionnaires to gather information on improvements in bloating, digestion, stool regularity, stool quality, and gas. Survey-based assessments (0-5, 0-6 point scale) of changes in bloating, digestion, stool regularity, stool quality, and gas.
Change in scores on the Gastrointestinal Symptom Rating Scale (GSRS) [Time Frame: Baseline to 4
时间窗: 4 weeks
Use of validated questionnaire the GSRS to assess gastrointestinal symptoms.The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters reporting on Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents no symptoms and 7 represents severe symptoms.
次要结局
未报告次要终点