Randomized, Double-Blind, Placebo-Controlled Exploratory Study Assessing the Effects of Probiotic Supplementation on Gut Barrier Function, Immune Response, and Well-Being.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Gut barrier function
研究概览
简要总结
This randomized, double-blind, placebo-controlled exploratory study will evaluate the effects of daily probiotic supplementation on gut barrier function, immune-related markers, and well-being in healthy adults with mild to moderate perceived stress.
50 participants will be randomly assigned to receive either a probiotic supplement or placebo for 8 weeks. Blood and stool samples will be collected before and after the intervention to assess markers of gut barrier function, intestinal inflammation, gut microbiome composition, short-chain fatty acids, and immune function. Participants will also complete questionnaires on stress, quality of life, mood, digestive symptoms, and bowel habits. Safety will be evaluated throughout the study by monitoring adverse events and vital sign assessments.
详细描述
This is a prospective, randomized, double-blind, placebo-controlled, singlecenter, two-arm, parallel-group exploratory study in 50 healthy adults with mild to moderate levels of perceived stress.
The study lasts a total of 9 weeks per participant with a 1-week run-in period followed by 8 weeks of supplementation. The study includes three visits to the study site: a screening visit, a pre-intervention visit (at the end of the run-in period), and a post-intervention visit after 8 weeks of supplementation. After providing written informed consent, participants will undergo screening to confirm eligibility. Screening assessments include demographic information, medical history, concomitant medication, body weight, height, body mass index, blood pressure, pulse, and assessment of chronic stress. A pregnancy test will be performed for female participants, as applicable.
Participants are randomly assigned to receive either the probiotic supplement or a matching placebo. Randomization will be stratified by sex. Participants will take one capsule once daily before or with dinner for 56 days.
The probiotic product contains fructooligosaccharides, selected probiotic bacterial strains, and vitamins. The placebo does not contain those active ingredients and is similar in appearance, taste and smell. Treatment allocation will remain blinded to participants and the study team involved in study assessments. Blood and stool samples will be collected before and after the intervention. Laboratory assessments will include markers related to gut barrier function, intestinal inflammation, gut microbiome composition, short-chain fatty acids, and systemic immune function. Further, participants will complete questionnaires assessing quality of life, health-related quality of life, depression, anxiety, stress, bloating, flatulence, stool consistency, and stool frequency. Safety will be evaluated by monitoring adverse events, blood pressure, and pulse. During the complete study duration, participants are instructed to maintain their usual lifestyle and diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteer is healthy at the time of screening according to participant's own statements.
- •TICS SSCS score ≥
- •Male or female aged ≥18 and ≤65 years at the time of screening.
- •BMI ≥18.5 and ≤29.9 kg/m².
- •Volunteer is able and willing to comply with the study instructions.
- •Volunteer is suitable for participation in the study according to the investigator/study personnel.
- •Voluntary, written informed consent to participate in the study.
排除标准
- •No command of local language.
- •Currently diagnosed neurological or psychiatric disorders.
- •Gastrointestinal disorders including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or other conditions that might affect the gut environment.
- •Contraindication or allergy to any ingredient in the verum or Placebo product.
- •Use of drugs in the previous 4 weeks before the beginning of intervention.
- •Use of laxatives and labelled pre#and probiotics in the previous 2 weeks before the beginning of intervention.
- •Participation in another study with any investigational product within 30 days of screening, or less than five elimination half-lives after the last administration of the investigational product (whichever period is longer) or during the study.
- •History of drug (recreational) or alcohol abuse.
- •Bowel preparation for investigative procedures in the 4 weeks prior to screening.
- •Surgical resection of any part of the bowel (excl. appendectomy).
- •Pregnant or lactating female, or pregnancy planned during study period, or women of childbearing potential who are not using a medically approved form of contraception (at least three months prior to screening).
- •Regular smoking.
研究组 & 干预措施
Probiotic Supplement
Fructooligosaccharides, selected probiotic strains, vitamins
干预措施: Probiotic capsules (Dietary Supplement)
Placebo
Maltodextrin, corn starch
干预措施: Placebo (Other)
结局指标
主要结局
Gut barrier function
时间窗: During 8 week intake phase
Gut barrier function
Immune function
时间窗: During 8 week intake phase
Immune function
Well-being
时间窗: During 8 weeks intervention phase
Perceived (health-related) quality of life, stress, anxiety, depression
次要结局
未报告次要终点