Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Placebo-Controlled Clinical Trial To Evaluate The Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Clinical Outcome Measure: Efficacy
研究概览
简要总结
A Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Probiatop in the Treatment of Digestive Symptoms. Phase IV. The casuistic presented in this protocol is 150 participants randomized at a 1:1 ratio (75 receiving Probiatop and 75 receiving placebo), balanced by age, sex, prebiotic intake* and summation of the Gastrointestinal Symptom Rating Scale (GSRS) questions related to the domains of diarrhea (questions 11, 12, and 14), indigestion (questions 6, 7, 8, and 9), and constipation (questions 10, 13, and 15) separated by intensity and frequency. Participants with recurrent digestive symptoms for at least 3 months, with a score of 21 on the sum of questions 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 of the GSRS (corresponding to the domains diarrhea, indigestion and constipation) will be randomized to Probiatop or placebo.
详细描述
This is a Phase IV clinical trial that will evaluate the efficacy and safety of Probiatop (investigational product). Participants with recurrent digestive symptoms for at least 3 months, with a score of 21 on the sum of questions: 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 of the GSRS questionnaire (corresponding to the domains diarrhea, indigestion and constipation) will be randomized to Probiatop or placebo. It will also be applied by electronic means (whatsapp link) on D7, D21 and D35. On these days participants will also be contacted by telemedicine to collect adverse events adverse events and data on concomitant medication. Treatment will be discontinued on D42. On D70 the participant will again be contacted by telemedicine for final data collection.
Product under investigation and dosage: Probiatop composition: association of probiotic strains containing 1 g/sachet of 1 x 109 CFU Bifidobacterium lactis HN019 (ATCC SD 5674), 1 x 109 CFU Lactobacillus acidophilus NCFM (ATCC SD 5221), 1 x 109 CFU Lactobacillus rhamnosus HN001 / Lacticaseibacillus rhamnosus HN001 (ATCC SD 5675) and 1 x 109 CFU Lactobacillus paracasei Lpc-37 / Lacticaseibacillus paracasei Lpc-37 (ATCC SD 5275). Placebo composition: collagen
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
- Double (Participant, Investigator)
盲法说明
The study will be double-blind. The participants and the investigator will be "blinded" in the study, in which they will not know the treatment that each participant will be receiving.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female gender;
- •Age ≥ 18 years;
- •BMI ≥ 18, 5 ≤ 29.9 Kg/m2;
- •Complaint of recurrent digestive symptoms for at least 3 months with value ≥ 21 of the sum of questions: 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15 of the GSRS in frequency or intensity separately.
排除标准
- •Extreme eating habits for which the primary intervention is dietary re-education: more than 7 of the of the 14 main meals of the week (lunch and dinner) based on ultra-processed products (industrial formulations formulations such as: filled cookies, "packaged" snacks packaged" snacks, soft drinks and "instant" noodles, frozen frozen and ready-to-eat products such as pasta, pizzas hamburgers, nuggets, sausages, etc) or "fast food" or average consumption of soft drinks exceeding 2 glasses per day.
- •Alcoholism (DSM V): disorder defined as the repetition problems resulting from the use of alcohol that lead to clinically significant clinically significant impairment and/or suffering;
- •Diabetes mellitus type I or II;
- •Chronic diarrhea with signs of malabsorption (weight loss bulky and exceptionally smelly stools), AND/OR bleeding, AND/OR presence of mucus in the stool, bleeding without diarrhea;
- •Weight loss ≥ 10% in the past 6 months;
- •Any recent change in eating habit, including veganism;
- •Clinically significant illnesses at the discretion of the Investigator;
- •Use of medications or supplements that may modify gastrointestinal function in the 30 days prior to randomization, especially proton pump inhibitors antacids, laxatives, constipating agents (loperamide, racecadotrilla, tricyclic antidepressants), other probiotics and prebiotics (containing dietary fiber including inulin, resistant starch, cellulose, oligofructose, fiber oligofructose, soy fiber, polydextrose, Kefir, Kombucha, and others);
- •Use of antibiotics in the 3 months prior to randomization for any indications, including Helicobacter pylori;
- •History of digestive surgery;
- •Active cancer or cancer under treatment in the 6 months prior to randomization, except operated basal cell carcinoma;
- •History of allergy or hypersensitivity to probiotics or components of the formula;
- •Pregnant and lactating women.
研究组 & 干预措施
Probiatop
Probiotic used in the reconstitution and rebalancing of the intestinal microbiota.
Association of probiotic strains containing 1 g/sachet of 1 x 109 Bifidobacterium lactis HN019, 1 x 109 Lactobacillus acidophilus, 1 x 109 Lactobacillus rhamnosus HN001 / Lacticaseibacillus rhamnosus HN001 and 1 x 109 Lactobacillus paracasei Lpc- 37 / Lacticaseibacillus paracasei Lpc-37.
干预措施: Probiatop (Drug)
Hydrolized collagen
Hydrolyzed collagen is approved by Agência Nacional de Vigilância Sanitária (ANVISA) including for use in infants (ANVISA, IN NO. 28, OF JULY 26, 2018). Its use as a placebo is convenient, as it dissolves well in water, and promotes good masking. Based on literature surveys on hydrolyzed collagen and the intestinal microbiota, it was verified that the dose used (1 g) would not promote relevant functional impact in the context of the habitual Brazilian people diet.
干预措施: Placebo (Other)
结局指标
主要结局
Clinical Outcome Measure: Efficacy
时间窗: 42 days
Multicriteria evaluation of the impact of Probiatop on gastrointestinal symptom reduction symptoms by the Gastrointestinal Symptom Rating Scale (GSRS).
次要结局
- Clinical Outcome Measure: Safety(Day 0 to Day 42)