Efficacy of MYCOBIOTIC® In Children and Adults With Abdominal Symptoms. Double Blind, Placebo Controlled, Prospective, Cross-over Multicenter Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 12
- 主要终点
- MYCOBIOTIC® influence for the intensity of stool frequency and consistency
研究概览
简要总结
This is a prospective, randomised, double blind, placebo controlled, parallel arm, cross-over, multicentre study conducted in a population of children and adults with abdominal symptoms observed at outpatient primary health care centres.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adults age >3 up to ≤ 75 years old. Boys and girls aged 3-15 years
- •Presence of abdominal symptoms
- •Informed consent for participation in the study signed by children' parents/ legal caregivers and child above 13 years old, all adults patients.
排除标准
- •Chronic intestinal disease, immunodeficiency or immunosuppressive treatment.
- •Chronic or acute diarrheal disease.
- •Use of laxatives or antydiarrhoeal treatment within the week before inclusion in the study.
- •Antibiotic treatment for the last four weeks before inclusion in the study.
- •Intake of probiotic products for the last two weeks before inclusion in the study
- •Known hypersensitivity to any of the ingredients in the probiotic product or the placebo (corn starch, magnesium stearate ± bacterial culture).
结局指标
主要结局
MYCOBIOTIC® influence for the intensity of stool frequency and consistency
时间窗: Day 21+/-3; Day 42+/-3, Day 49 +/-3
to assess if administration of MYCOBIOTIC® have influence to the intensity of the abdominal symptoms reported by parents or caregivers in questionaire- stool frequency and consistency
MYCOBIOTIC® influence for the intensity of abdominal bloating
时间窗: Day 21+/-3; Day 42+/-3, Day 49 +/-3
to assess if administration of MYCOBIOTIC® have influence to the intensity of the abdominal symptoms reported by parents or caregivers in questionaire- abdominal bloating
MYCOBIOTIC® influence for the intensity of vomiting
时间窗: Day 21+/-3; Day 42+/-3, Day 49 +/-3
to assess if administration of MYCOBIOTIC® have influence to the intensity of the abdominal symptoms reported by parents or caregivers in questionaire- vomiting
MYCOBIOTIC® influence for the intensity of abdominal pain;
时间窗: Day 21+/-3; Day 42+/-3, Day 49 +/-3
to assess if administration of MYCOBIOTIC® have influence to the intensity of the abdominal symptoms reported by parents or caregivers in questionaire- abdominal pain;
MYCOBIOTIC® influence for the intensity of abdominal distention
时间窗: Day 21+/-3; Day 42+/-3, Day 49 +/-3
to assess if administration of MYCOBIOTIC® have influence to the intensity of the abdominal symptoms reported by parents or caregivers in questionaire- abdominal distention
次要结局
- Reducuction of the rate of patients with stool culture positive for Candida sp.(Day 42 +/-6)