CTRI/2018/02/011654已完成2 期
A Prospective, Interventional, Randomized, Double-blind and Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bacillus coagulans LBSC in Subjects with Irritable Bowel Syndrome.
Advanced Enzymes Technologies Ltd2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年6月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 1. Assessment of change in Gastrointestinal symptoms frequency assessment using DSFQ on 5-point Likert scale.
研究概览
简要总结
A Prospective, Interventional, Randomized, Double blind, Placebo Controlled Clinical trial to evaluate the Efficacy and safety of Bacillus coagulans LBSC in Subjects with Irritable Bowel Syndrome. Total of 40 Subjects was Enrolled for the study to Evaluate the Efficacy and Safety . Bacillus coagulans LBSC is used in the treatment of Irritable Bowel Syndrome .
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •Male and females aged 18 and 65 yrs.
- •completed years (both inclusive) with diagnosis of IBS as per Rome IV criteria with following symptoms for more than 3 months
- •Abdominal discomfort such as mild pain, cramping, bloating,
- •Altered bowel habit indicated by frequent diarrhea or constipation
- •Functional dyspepsia
- •Written informed consent by study participants.
排除标准
- •On antibiotics or laxatives within the preceding 6 weeks.
- •Presence of inflammatory bowel disease
- •Presence of acute GI tract infection
- •Presence of fever, abdominal mass, signs of bowel obstruction
- •History of colon cancer or diverticulitis
- •Infection by human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus
- •Patients with celiac disease defined by biopsy of the duodenal mucosa.
- •History of scleroderma and gastroparesis
- •Hypothyroidism.
结局指标
主要结局
1. Assessment of change in Gastrointestinal symptoms frequency assessment using DSFQ on 5-point Likert scale.
时间窗: Screening to End of Treatment
2. Assessment of change in gastrointestinal symptoms severity using IBS-SSS.
时间窗: Screening to End of Treatment
3. Assessment of change in stool consistency using Bristol stool chart
时间窗: Screening to End of Treatment
次要结局
- Assessment of safety of investigational product:(1. Adverse event)
研究者
研究点 (2)
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