A Multi-Center, Double Blind, Randomized, Parallel-Group, Placebo-controlled Study to Evaluate the Safety and Efficacy of Bacillus Coagulans Unique IS2 capsules in the Treatment of Functional Constipation in Adults.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Treatment success (defined as 3 or more spontaneous stools per week)
研究概览
简要总结
This is a prospective, double-blind, multi-centric, randomized, parallel-group study to evaluate the safety and efficacy of Bacillus Coagulans IS2 capsules in the treatment of functional constipation in adults. In all, 100 subjects will be randomized by block randomization technique in order to enroll subjects in a targeted ratio of 1:1 (test: placebo). Test group and placebo group will have approximately equal number of subjects in different age groups of adults. Subjects who have diagnosis of functional constipation according to Rome III criteria in whom, slow colonic transit has been ruled out will be randomized to receive either test or placebo capsules. The IP will be administered for a period of 28 days orally one capsule per day.
Subjects will be evaluated for the treatment success (defined as 3 or more spontaneous stools per week), stool frequency and consistency (according to Bristol Stool Form Scale), difficulty of defecation, defecation pain and abdominal pain by (Constipation Scoring System [CSS]†scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female subject aged between 18 and 65 years old (both inclusive).
- •2.Has diagnosis of functional constipation according to Rome Criteria III.
- •3.Willing to give IEC approved informed consent.
- •Willing to abide by the study requirements.
排除标准
- •1.Subjects who have undergone major abdominal surgery.
- •2.Subjects with a documented history of slow colonic transit.
- •3.Presence of any concomitant diseases such as organic GI diseases and/or lactose and gluten intolerance; medical or psychiatric illness 4.Subjects with clinical features suggestive of alarming symptoms (rectal bleeding, weight loss, etc.) 5.Family history of peptic ulcer, colorectal cancer, or IBD 6.Abnormal laboratory data or thyroid function.
- •7.Participated in any clinical trial in the past 90 days.
- •8.Have received any probiotic formulation in the past 30 days.
- •9.Known or expected hypersensitivity to any of the active substances or excipients.
- •10.Subject is pregnant or lactating.
- •11.Subject allergic or atopic to any of the ingredients of the study medication.
结局指标
主要结局
Treatment success (defined as 3 or more spontaneous stools per week)
时间窗: Baseline (Day 0) and Day 29 (End of treatment)
次要结局
- Changes from baseline at EOS in:(a.Stool frequency)