Evaluation of the Synergistic Effect of Combining a Prebiotic and a Postbiotic on Intestinal Discomfort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change from baseline in the intensity and frequency of intestinal symptoms
研究概览
简要总结
This study aims to investigate the beneficial effects of the daily consumption of a synbiotic formulation-combining a prebiotic (Berberine, BBR) and a postbiotic (inactivated Bifidobacterium Longum, B.longum)-in adults experiencing intestinal discomfort.
详细描述
This study is designed as a randomized double-blind placebo-controlled interventional study. One hundred and forty individuals aged between 18 and 75 years and experiencing a measurable level of intestinal discomfort will be randomly allocated to one of the four groups (35 subjects per group): control, prebiotic only, postbiotic only, or combination of both. Subjects will receive their assigned supplementation for 8 weeks. Intestinal discomfort will be measured through tests and questionnaires at baseline, mid-intervention (week 4), at the end of intervention (week 8), and after a follow-up period of 4 weeks (week 12).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Woman or man, aged of 18 to 75 years (inclusive);
- •Subject with a measurable level of intestinal discomfort, assessed using a questionnaire inspired by the ROME IV criteria. Eligible participants must meet all of the following conditions:
- •Experience recurrent abdominal pain present for at least three months and occurring on a regular basis;
- •The abdominal discomfort must have a low to moderate impact on quality of life;
- •In addition, participants must report at least two of the following gastrointestinal symptoms:
- •Constipation
- •Excessive flatulence
- •Sensation of incomplete evacuation
- •Urgent need to defecate;
- •Body Mass Index (BMI) between 18 and 30 kg/m² (inclusive);
- •Provision of signed and dated informed consent form;
- •Stated willingness to comply with all study procedures and availability for the duration of the study;
- •Stated willingness to maintain their usual life habits (diet, physical activity, alcohol consumption…);
- •Speaking French.
排除标准
- •Subject with severe or chronic medical conditions which, in the opinion of the Principal Investigator, could interfere with the evaluation of the study outcomes or compromise participant safety;
- •Subject with a diagnosed gastrointestinal disorder (e.g., Crohn's disease, inflammatory bowel disease, or other chronic digestive conditions);
- •Subject with type 1 or type 2 diabetes;
- •Subject who has taken, within the 28 days prior to the screening visit, or are currently taking, drugs or food supplements intended to improve intestinal comfort, or any other substances that, in the opinion of the Principal Investigator, could interfere with intestinal comfort assessment or transit frequency (prebiotics, laxative, anti-diarrheal, probiotics, postbiotics, synbiotics). These products will also be avoided for the duration of the study;
- •Subject who has taken antibiotics within the 3 months prior to the screening visit. These products will also be avoided for the duration of the study;
- •Subjects undergoing medical treatment which, in the opinion of the Principal Investigator, could interfere with the evaluation of the study criteria or with participant safety: antidepressants, immunosuppressants, antipsychotics, antispasmodics, anxiolytics, neuroleptics. These products will also be avoided for the duration of the study;
- •Subject who had undergone bariatric surgery;
- •Subject consuming more than 5 cups of coffee per day;
- •Subject currently using drugs and/or with a history of drug addiction within the past 2 years;
- •Subject with regular alcohol consumption exceeding 3 standard drinks per day (10 g of pure alcohol each), equivalent to 3 glasses of wine (12 cl), 3 glasses of beer (5°, 25cl), or 3 glasses of spirits (18°, 7 cl);
- •Subject with known hypersensitivity to any component of the study product;
- •Subject currently participating in another interventional trial;
- •Woman of childbearing age who is pregnant or breastfeeding or who wishes to become pregnant within the next 12 weeks or who is not using an adequate method of contraception (e.g. oral contraception, IUD, abstinence, ...).
研究组 & 干预措施
Berberine
Dietary supplement - Berberine
干预措施: Berberine (Dietary Supplement)
Bifidobacterium longum
Dietary supplement - Bifidobacterium longum
干预措施: Bifidobacterium longum (Dietary Supplement)
Bifidobacterium longum and Berberine
Dietary supplement - Bifidobacterium longum and Berberine
干预措施: Bifidobacterium longum and Berberine (Dietary Supplement)
Placebo
Dietary supplement - Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change from baseline in the intensity and frequency of intestinal symptoms
时间窗: Throughout the entire study, approximately during 10 months
Comparison between groups in the change from baseline of the intensity and frequency of intestinal symptoms measured by Irritable Bowel Syndrome - Severity Scoring System (IBS-SSS)
次要结局
- Change from baseline in the intestinal-related quality of life(Throughout the entire study, approximately during 10 months)
- Change from baseline in the intestinal permeability(Throughout the entire study, approximately during 10 months)
- Change from baseline in the microbiota composition(Throughout the entire study, approximately during 10 months)
- Product satisfaction(Throughout the entire study, approximately during 10 months)
- Self-perceived gut symptoms enhancement(Throughout the entire study, approximately during 10 months)