CTRI/2022/09/045755已完成4 期
A Randomized, Double-Blind, Active-Controlled, 4-week Parallel GroupStudy to Evaluate the Efficacy and Safety of Lactitol and Probiotic Bacillus Coagulans SC208 in patients with Chronic Idiopathic Constipation.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- stools per week).
研究概览
简要总结
This study is a randomized, double blind, Active control, 4 weekparallel group, to evaluate the safety and efficacy of Lactitol and ProbioticBacillus Coagulans SC208 15 ml daily or Lactitol 15 ml daily for 28 Days in 40(20 patients with each arm) patients with Chronic Idiopathic Constipation thatwill be conducted in approximately 2 centers in India. The primary outcomemeasures Treatment success (defined as 3 or more spontaneous stools per week) at day 29. The secondary outcomes will betreatment success at day 29, Change in Bristol scale at day 8, 15 & 29.
Change in gut microbiome composition from baseline to Day 29 (through the faecalmicrobiome analysis).
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
- •Patients both males and females, between 18-65 years of age.
- •Patients who are known cases of Chronic Idiopathic Constipation (CIC) defined by Rome III diagnostic criteria Rome III defines functional constipation or chronic idiopathic constipation as the presence of two or more of the following for more than 6 months: a.
- •Straining during at least 25% of defecations.
- •Lumpy or hard stools in at least 25% of defecations.
- •Sensation of incomplete evacuation for at least 25% of defecations.
- •Sensation of anorectal obstruction/blockage for at least 25% of defecations.
- •Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor).
- •Fewer than three defecations per week.
- •Patients on stable medications (past 3 months) in case suffering from Diabetes Mellitus Type II.
- •Patients willing to abide by study procedures and provide voluntary written informed consent.
排除标准
- •Patients who have undergone major abdominal surgery.
- •Patients with concomitant diseases such as Gastrointestinal diseases and/or medical or psychiatric illness.
- •Patients with family history of peptic ulcer, colorectal cancer or IBD.
- •Patients with a documented history of slow colonic transit.
- •Patients with abnormal laboratory data ( i.e. with liver enzymes (ALT and AST) more than 3 times ULN1 and/or bilirubin more than 1.5 times ULN1).
- •Patients with history of hypothyroidism or abnormal thyroid function.
- •Patients with history of renal impairment or abnormal renal function test ( i.e. Serum creatinine more than 2 times ULN1).
- •Any other laboratory value abnormality considered clinically significant by the Investigator.
- •Patients who participated in any clinical trial in the past 90 days.
- •Patients who have received any probiotic formulation in the past 30 days.
- •Patients with known or expected hypersensitivity to any of the active substances or excipients.
- •Patients who are pregnant or lactating.
- •Patients who are allergic or atopic to any of the ingredients of the study medication.
- •Patients suffering from any other medical condition in opinion of the Investigator that may put the patient at a significant risk, may have confounded study results, or may have interfered significantly with the patients participation in the study.
- •Patients with use of any prescription and/ or OTC laxatives during the 48 hour period prior to the first dose of study medication.
结局指标
主要结局
stools per week).
时间窗: Day 29.
Treatment success (defined as 3 or more spontaneous
时间窗: Day 29.
次要结局
- A) Treatment success (defined as 3 or more spontaneous(stools per week) at Day 8, 15)
研究者
研究点 (1)
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