Evaluation of the Acceptability of a Multi-strain Probiotic Supplement (Smile Probio 45B) in Healthy Adults: an Open-label Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Daily compliance and stool consistency using the Bristol Stool Form Scale
研究概览
简要总结
The goal of this clinical trial is to examine the compliance and acceptability of the probiotic Smile Probio 45B in healthy adults, as well as its effect on gastrointestinal symptoms, fatigue levels, and quality of life.
Specifically, the study examines the effect of probiotic intake on improving health-related quality of life, reducing self-reported gastrointestinal symptoms such as bloating, as well as regulating stool consistency and frequency. In addition, its impact on participants' self-reported energy levels is investigated, with a particular emphasis on reducing fatigue symptoms.
Participants will:
- take 1 capsule daily (with a main meal) during the first and second week of the intervention, and 3 capsules daily (after each main meal) during the third and fourth week of the intervention, for a total duration of 30 days.
- complete a three-day food record on a weekly basis.
- record their daily bowel habits, including the number of bowel movements and their consistency/form, according to the Bristol Stool Chart, which will be provided to them.
- complete questionnaires assessing health-related quality of life [WHOQOL-BREF (World Health Organization Quality of Life)],a health status questionnaire [EQ-5D (EuroQol-5D)] and a questionnaire evaluating energy levels and fatigue [Chalder Fatigue Scale (CFQ)].
- complete, at baseline and at the end of each intervention week a weekly symptom assessment questionnaire.
- undergo body composition assessment at the beginning, midpoint, and end of the study.
- complete an acceptability questionnaire at the end of the intervention.
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 and women aged over 18 years
- •Body Mass Index (BMI) >18 kg/m² and <30 kg/m²
- •No use of antibiotics in the past month
- •Willingness to provide informed consent
排除标准
- •Pregnancy or breastfeeding
- •Age under 18 years
- •Diagnosis of a chronic autoimmune disease (e.g., Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriasis)
- •Diagnosis of type I or II diabetes
- •Current use of immunosuppressive medications
- •Current use of antibiotics or use of antibiotics within the past month
- •Current use of other supplements such as probiotics, prebiotics, or synbiotics
- •Kidney or liver disease
- •Self-reported allergy to any component of the probiotic
- •Psychological conditions affecting the ability to provide informed consent (e.g., dementia, psychosis, substance use)
- •Gastrointestinal surgery within the last 6 months
研究组 & 干预措施
Probiotic Intervention
Participants will receive probiotic supplement for 4 weeks
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Daily compliance and stool consistency using the Bristol Stool Form Scale
时间窗: From enrollment to the end of treatment at 4 weeks
Participants will record their daily compliance and stool consistency using the Bristol Stool Form Scale. Adherence to the intervention will be evaluated by recording the number of days the probiotic was consumed. To prevent potential non-compliance, participants weill be contacted via telephone on a weekly basis. At the conclusion of the study, participants will be asked to return all empty packaging and any remaining capsules.
Acceptability of the probiotic using an acceptability questionnaire
时间窗: Immediately after the intervention
At the end of the intervention, participants will complete an acceptability questionnaire, including questions regarding ease of use of the probiotic, perceived product safety, and intention to recommend it to others.
次要结局
- Effect of Smile Probio 45B on gastrointestinal symptoms(From enrollment to the end of treatment at 4 weeks)
- Effect of Smile Probio 45B on fatigue levels(From enrollment to the end of treatment at 4 weeks)
- Effect of Smile Probio 45B on quality of life using the EQ-5D-5L questionnaire(From enrollment to the end of treatment at 4 weeks)
- Effect of Smile Probio 45B on quality of life using the WHOQOL-BREF questionnaire(From enrollment to the end of treatment at 4 weeks)
研究者
Vaios Svolos
Dietitian, Postdoctoral Researcher
University of Thessaly