A Randomized, Multicenter, Open Label, Two Arm, Prospective, Parallel Study to Evaluate the Impact of Addition of Synbiotic Combination to Lactulose in Management of Functional Constipation.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- 1. Treatment success (defined as 3 or more spontaneous stools per week)
研究概览
简要总结
This is a randomized, multicenter, open label, two arms, prospective, parallel study to evaluate the impact of addition of synbiotic combination to lactulose in management of functional constipation.
A total of 80 subjects (40 subjects in each group) will be enrolled in this study to get 60 completed subjects (30 subjects in each group) for evaluation at the end of the study.
Note: 40 subjects will be enrolled in the test group and 40 subjects will be enrolled in the reference group.
For Microbiome Cohort – Sample of 24 subjects (12 subjects in each arm) will be analyzed to get data of 20 subjects (10 subjects in each arm) at the end of the study.
Note: Test Group – Sample of 12 subjects. Reference Group – Sample of 12 subjects
The study duration will be of approximately 29 days (4 weeks) which includes screening and treatment period.
Clinical evaluation will be done at following visits:
Visit 1- Day 1: Screening Visit/Randomization Visit/ Baseline Visit (Physical visit)
Visit 2 - Day 8 (± 2 days): Interim visit (Virtual / Telephonic Visit)
Visit 3 - Day 15 (± 2 days): Interim visit (Virtual / Telephonic Visit)
Visit 4 – Day 22 (± 2 days): Interim visit (Virtual / Telephonic Visit)
Visit 5- Day 29 (± 4 days): End of treatment/End of Study/ Early Termination Visit. Visit 5 will be physical for microbiome cohort and can be physical/virtual/telephonic for the rest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
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 or female subjects with age of 18-65 years (both years inclusive).
- •Subject diagnosed with functional constipation/chronic constipation as per Rome IV criteria is two or more of the following: a) Straining during more than ¼ (25%) of defecations b) Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations c) Sensation of incomplete evacuation more than ¼ (25%) of defecations d) Sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations e) Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor) f) Fewer than three SBM per week g) Loose stools are rarely present without the use of laxatives.
- •h) Insufficient criteria for irritable bowel syndrome 3)Subject must be willing and able to administer the study medication as directed, comply with study instructions and commit to all subsequent visits for the duration of the study.
- •Subject who agrees to refrain from making any new, major life-style changes that may have affected constipation symptoms (e.g., starting a new diet, fasting for prolonged duration during study period or changing his or her exercise pattern) from the time of signature of the ICF to the last trial visit.
- •Subject having good general health and free of any disease state or physical condition that might impair evaluation of constipation or which in the Investigators opinion exposes the subject to an unacceptable risk by study participation.
- •Subject and/or LAR willing to give their written informed consent to participate in the study.
排除标准
- •1.Female subject who is pregnant, lactating or planning to become pregnant during the study. 2.Subject with history of diabetes. 3.Subject with history of hypersensitivity or allergy to active substance and/or any of the study medication ingredients. 4.Subject who have previously undergone any major abdominal surgery. 5.Subject with documented history of slow colonic transit. 6.Subject currently having any concomitant diseases such as organic GI diseases and/or lactose and gluten intolerance. 7.Subject having clinical features suggestive of alarming symptoms (e.g., rectal bleeding, weight loss etc.). 8.Subject having family history of peptic ulcer, colorectal cancer or IBD, Abnormal laboratory data or thyroid function. 9.Subject who has used any fiber supplement/laxative/probiotic in the 2 weeks prior to screening or currently using any formulation/ over the counter drugs/ Ayurvedic medicine or following crash diets- intermittent fasting or ketogenic diets. 10.Subject with a structural abnormality of the gastrointestinal (GI) tract or a disease or history of a condition that could affect GI motility. 11.Subject who previously had a fecal impaction that required hospitalization or emergency room treatment, or had a history of cathartic colon, laxative or enema abuse, ischemic colitis, or pelvic floor dysfunction (unless successful treatment had been documented by a normal balloon expulsion test). 12.Subject with an acute or chronic condition that, in the investigator’s opinion, would limit the subject’s ability to participate or complete in this study. 13.Subject who has an unstable medical or psychological condition(s) evident prior during screening or that could, in the Investigator’s opinion, be exacerbated during the course of the study. 14.Subject with a recent history (during the 12 months before the Randomization Visit) of drug or alcohol abuse. 15.Subject who has used an Investigational drug in any form or participated in any clinical trial within 30 days prior to first administration of the study medication. 16.Subject who is institutionalized. 17.Subject who lives in the same household as currently enrolled subject. 18.Subject with presence of any other medical condition or abnormal conditions that might adversely impact the safety of the study subjects or confound the study results. 19.For Microbiome cohort.
- •exclude subjects on antibiotics within the last 4 weeks, on probiotics/prebiotics/high fibre supplements for 4-6 weeks.
结局指标
主要结局
1. Treatment success (defined as 3 or more spontaneous stools per week)
时间窗: 1. Number of stools at baseline (Day 01), Day 8 (± 2 days), Day 15 (± 2 days), Day 22 (± 2 days) and Day 29 (± 4 days)]. | 2. Change from baseline (Day 01) to Day 8 (± 2 days), Day 15 (± 2 days), Day 22 (± 2 days) and Day 29 (± 4 days)]
2. Change from baseline in weekly frequency of Spontaneous Bowel Movement (SBM)
时间窗: 1. Number of stools at baseline (Day 01), Day 8 (± 2 days), Day 15 (± 2 days), Day 22 (± 2 days) and Day 29 (± 4 days)]. | 2. Change from baseline (Day 01) to Day 8 (± 2 days), Day 15 (± 2 days), Day 22 (± 2 days) and Day 29 (± 4 days)]
次要结局
- 1. Proportion of subject with complete spontaneous bowel movement (CSBM)(2. Proportion of subject with an SBM within 24 hours after the first dose of study drug.)
研究者
Dr Sagar Katare
Dr. Reddys Laboratories