Efficacy Study of the Probiotic Food Supplement PROBAFLOR for Maintaining Intestinal Well-being: Single-centre, Controlled, Randomized, Parallel Group, Double-blind Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- maintenance and/or improvement of intestinal health and health-related quality of life (through the GIQLI questionnaire)
研究概览
简要总结
It is now known that intestinal health has a strong influence on the entire body. Recent research advances have demonstrated the involvement of the intestinal microbiota in the well-being of the intestine. Preventive medicine is increasingly perceived as important in medical and economic terms, particularly in the field of gastroenterology. An innovative approach to support gut health is based on the use of modulators of the intestinal microbiome or gastrointestinal barrier, such as probiotics or prebiotics. The rationale for this study is therefore based on the hypothesis that the combination of 11 probiotic strains, conveyed through the PROBAFLOR food supplement, can play a positive role in maintaining normal intestinal function, bringing benefits to the subject who takes this supplement.
详细描述
This is a randomized, double-blind, placebo-controlled intervention study with a duration of 3 months of intervention + 1 month of follow-up, on biological samples. Eligible participants will be randomized and receive either the probioic or placebo supplement to consume daily for 3 months. Three check-in visits will occur, one at the screening, the second one afetr the 3-months intervention and the final one after 1 month of followup. Participants will be expected to complete a daily study diary documenting their investigational product use/adverse events and a daily bowel habits diary documenting each bowel movement. Stool samples, and questionnaires will be completed for study outcome analysis.
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
- Triple (Participant, Care Provider, 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
- •men and women aged between 18 and 65;
- •healthy based on medical history;
- •commitment to comply with all firm procedures;
- •commitment to refrain from using any home remedies to control gastrointestinal problems, particularly if live bacteria are involved;
- •signature of informed consent.
排除标准
- •use of probiotics continuously, in the two months prior to enrollment;
- •use of antibiotics in the month before enrollment;
- •chemotherapy treatments;
- •diagnosis of respiratory, hepatic and/or renal failure;
- •Clinically significant diseases of the gastrointestinal tract (examples include, but are not limited to, celiac disease, gluten intolerance/sensitivity, inflammatory bowel disease);
- •Women who are pregnant, breastfeeding or planning to become pregnant during the study;
- •Allergy or sensitivity to the active or inactive ingredients of the investigational product.
研究组 & 干预措施
Treated group
Dietary supplement: PROBAFLOR 20 Billion CFU/dose, serving size = 1 capsule/day
干预措施: PROBAFLOR (Dietary Supplement)
Placebo group
Placebo Placebo product, serving size = 1 capsule/day
干预措施: Placebo (Other)
结局指标
主要结局
maintenance and/or improvement of intestinal health and health-related quality of life (through the GIQLI questionnaire)
时间窗: Baseline, After 3 months of intervention, at follow-up (one month after the end of administration
次要结局
- Intestinal microbiota composition(Baseline, After 3 months of intervention, at follow-up (one month after the end of administration)
- SCFA determination(Baseline, After 3 months of intervention, at follow-up (one month after the end of administration)
- Changes in quality of life.(Baseline, After 3 months of intervention, at follow-up (one month after the end of administration)
- Changes in intestinal functionality(Baseline, After 3 months of intervention, at follow-up (one month after the end of administration)
- Changes on gastrointestinal symptoms(Baseline, After 3 months of intervention, at follow-up (one month after the end of administration)