CTRI/2014/05/004587已完成2 期
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Synbiotic Formulation in Human Subjects
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ITC Limited
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Mean reduction of Colonic Transit, Colonic Geometric Center at 24 hours between the groups by Scintigraphy as compared to baseline
研究概览
简要总结
This study is a randomized, double blind, parallel group multicenter study to evaluate the effect and safety of synbiotic formulation in comparison to placebo in 90 subjects with constipation. The primary objective of this study will be to evaluate the effect of a synbiotic (probiotic and prebiotic combination) formulation on gastrointestinal parameters primarily gastrointestinal transit time (bowel habit and transit time) and improvement of abdominal symptoms (distension, bloating, flatulence, abdominal pain).
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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
- •Males or females aged from 18 to 65 years, both inclusive.
- •Subjects with active symptoms of abdominal pain or discomfort.
- •IBS diagnosed by Rome III criteria:
- •Females of child-bearing potential should be willing to use adequate methods of contraception.
- •Subjects willing to provide a written and recorded informed consent
- •Subjects with no regular use of fibre supplementation (e.g. Fybogel, Lactulose) over the week prior to the screening visit.
排除标准
- •Major gastrointestinal complication (e.g. Crohns disease, ulcer, cancer).
- •The subject has a serious, unstable medical condition, such as lung disease, uncontrolled blood pressure, uncontrolled thyroid function, a physical or medical disability or an advanced medical condition.
- •The subject has been treated for a malignancy within the last 5 years (except BCC or SCC skin cancer).
- •The subject had previous significant gastric or intestinal surgery (except appendectomy and gall bladder surgery).
- •IBS subtype other than IBS associated with Constipation.
- •Diarrhoea (more than 3 bowel movements per day).
- •Consumption of probiotics or prebiotics within 2 weeks of randomization.
- •Antibiotic use within 4 weeks of randomization.
- •Laxative or other constipation medication use within 2 weeks of randomization.
- •Subjects on the ongoing therapies with the drugs known to effect gut motility (e.g. laxatives, prokinetics, etc).
- •Consumption of IBS medications, anti-depressants, pain reliever medications within ten days prior to treatment or during treatment.
- •Subject with eating disorder.
- •Known allergies to any substance in the study product, including lactose intolerance and galactosemia.
- •Pregnant or lactating women.
- •History of alcohol, drug, or medication abuse.
结局指标
主要结局
Mean reduction of Colonic Transit, Colonic Geometric Center at 24 hours between the groups by Scintigraphy as compared to baseline
时间窗: 24 hours
次要结局
- Change in Colonic Filling(6 hours)
- Change in Half Time (t½) of Gastric Emptying of Solids(0,1,2 Hours)
- Relief from abdominal symptoms between the groups by Subject Global Assessment of Relief using a 5-point Likert scale(baseline to Day 4, Day 9, Day 16, Day 24 and Day 38)
- Change in Investigator‟s Assessment on abdominal symptoms using a 5-point Likert scale between the groups(baseline to Day 9, Day 16, Day 24 and Day 38)
- Change in Subject‟s Assessment on abdominal symptoms (using a 5-point Likert scale between the groups.(baseline to Day 9, Day 16, Day 24 and Day 38)
- Change in number of stool frequency between the groups(baseline to Day 9, Day 16, Day 24 and Day 38)
- Change in stool consistency using the 7-point Bristol Stool Form Scale (BSFS) between the groups(baseline to Day 9, Day 16, Day 24 and Day 38)
- Change in ease of Stool passage between the groups(baseline to Day 9, Day 16, Day 24 and Day 38)
- Correlation between QoL Questionnaire and GI Transit [Colonic Geometric Center, Colonic filling at 6 hours (%) and Gastric emptying half-life (t½) (min)] between the groups(at baseline and Day 24)
- Change in fecal microflora using stool culture between the groups(from baseline to Day 16, Day 24 and Day 38)
- Change in quality of life using Quality of Life (QoL) questionnaire between the groups(from baseline to Day 9, Day 16, Day 24 and Day 38)
- Assessment of safety in terms of incidence of treatment emergent adverse events(From baseline to day 4, day 9, Day 16, Day 24 and Day 38)
研究者
研究点 (1)
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