Clinical Study to Assess the Effects of Prebiotic and Probiotic Supplement
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Changes in Gastrointestinal Symptoms (GSRS) Scores
研究概览
简要总结
Randomized, Crossover, Double-Blind, Placebo-Controlled, Single-Center Clinical Study with Daily Food Log, Stool Samples, Blood Draws, and Validated Questionnaires (GSRS, Bristol stool chart, and DQLQ) with Oral Dietary Supplement
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is a healthy male or female between the ages of 18 - 50 years, inclusive;
- •Subject indicates they have mild or moderate occasional digestive issues (bloating or mild discomfort) with no diagnosed chronic digestive or immune conditions;
- •Subject has signed a written Informed Consent and is willing and able to attend all visits and comply with study instructions;
- •Subject agrees to maintain their regular diet and exercise habits;
- •Subject agrees to limit alcohol consumption to 1 drink per day or no more than 7 drinks per week.
- •Females Only: Female subject of childbearing potential must agree to be on a form of birth control for at least 6 months prior to screening visit. Acceptable forms of birth control are: Abstinence (not having heterosexual sex), same-sex partner, double barrier (condom, diaphragm, or cervical cap with spermicidal foam, gel, or cream), vasectomized partner for at least 6 months prior to the screening visit. Birth control (such as the pills, intravaginal ring, or the arm implant) are not acceptable forms of birth control.
- •Subject agrees not to take any dietary supplements or medications throughout the clinical study;
- •Subject agrees to have four blood draws taken at the testing facility and agrees to collect stool samples (four times) as instructed.
- •Subject has an active email address and is capable of completing online questionnaires.
排除标准
- •Subject has severe digestive issues (e.g., IBS, Crohn's Disease, Ulcers, Severe Constipation, etc.);
- •Subject has allergies to dietary supplements or their ingredients;
- •Subject is currently taking medication(s) for a chronic condition;
- •(Females of Child Bearing Potential only) Subject is pregnant, nursing, or planning to become pregnant;
- •Subject has significant past/current medical history (e.g., previous diagnosis of gastrointestinal or metabolic conditions, cancer, liver or kidney disease);
- •Subject has any disease or condition (e.g., hepatic, multiple sclerosis, high blood pressure, renal, Thrombosis/Phlebitis, cardiac, pulmonary, digestive, hematological, neurological, locomotor or psychiatric disease) which in the opinion of the Investigator would compromise the safety of the subject;
- •Subject has travel plans and would be unable to attend all study visits;
- •Subject is currently taking any dietary supplements, vitamins and/or medications;
- •Subject is currently taking probiotics related to digestion or any products that may impact gut microbiota (e.g. probiotic supplements, yogurt, and/or fermented drinks);
- •Subject has used antibiotics in the last 3 months;
- •Subject has a positive medical history for cancer within the past 5 years;
- •Subjects has any planned surgeries and/or invasive medical procedures during the study;
- •Subjects is considered unreliable or unlikely to be available for the duration of the study;
- •Subject is an employee of the clinical site or the sponsor
研究组 & 干预措施
Placebo
Oral dietary supplement. Instructions: Take 1 gummy per day with or without food or water. Do not take more than 1 gummy per day.
干预措施: Placebo (Dietary Supplement)
Dietary Supplement with actives
Oral dietary supplement. Instructions: Instructions: Take 1 gummy per day with or without food or water. Do not take more than 1 gummy per day.
干预措施: Dietary Supplement with actives (Dietary Supplement)
结局指标
主要结局
Changes in Gastrointestinal Symptoms (GSRS) Scores
时间窗: from enrollment to end of study at 10 weeks
Weekly GSRS scores will be analyzed to assess changes in the severity and frequency of gastrointestinal symptoms across the active and placebo arms. Data will be compared between the active supplement and placebo groups and within each participant across different time points to measure crossover effects.
Changes in Stool Consistency (Bristol Stool Chart)
时间窗: from enrollment to end of study at 10 weeks
Daily stool consistency ratings will provide data on changes in bowel health and regularity. Average stool consistency scores will be compared across baseline, active treatment, and placebo phases.
次要结局
- Changes in Immune Biomarkers (Blood Samples) Levels(from enrollment to end of study at 10 weeks)
- Changes in Gut Microbiome Composition (Stool Samples)(from enrollment to end of study at 10 weeks)