CTRI/2015/02/005580招募中3 期
A Prospective, Randomised, Double-Blind, Placebo-Controlled, 4 week Parallel Group Study to Evaluate the Efficacy and Safety of Lactitol and Psyllium Alone and in Combination in Treatment of Constipation
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 6
- 主要终点
- Change in bowel movement frequency from baseline to Day 28 (EOS) within and between treatment groups.
研究概览
简要总结
A prospective, randomised, double-blind, placebo-controlled, 4 weekparallel group study to evaluate the efficacy and safety of Lactitol and Psyllium alone and in combination in treatment of constipation. The primary endpoint of the study is the Change in bowel movementfrequency from baseline to Day 28 (end of study [EOS]) within and between treatment groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female of age between 25 and 65 years 2.BMI between 18.5 and 29.9 kg/m2 3.Safety Blood and Urine tests without clinical significance 4.Self-reported constipation ≤ 3 stools per week for the last 3 months and during the run-in period 5.80 % compliance with study product during the run-in period 6.Ability of the participant (as evaluated by the investigator) to comprehend the full nature and purpose of the study including possible risks and side effects 7.Consent to the study and willing to comply with study product and methods 8.Willingness to maintain a stable diet throughout the study.
排除标准
- •1.Daily consumption of probiotics and prebiotics within 2 weeks prior of screening and during the run-in period 2.Use of laxative, fibre supplement, or other medications for treating constipation (e.g. prokinetic groups) within 2 weeks of screening and during the run-in period 3.Planned major changes in life style (i.e. diet, dieting, exercise level, travelling) 4.Pregnant or breastfeeding women; women planning to become pregnant during the study months.
- •5.Women after giving birth in the last 3 months 6.Known allergies to any substance in the study products 7.History of alcohol or drug abuse 8.Participation in a clinical trial with an investigational product or drug within 3 months prior to screening 9.Medications that exclude from participating in the study include: •antibiotic use during one month prior to start of the study •oral steroids use during one month prior to start of the study •use of anticholinergic medication, pain medication that include opiates or morphine, weight loss medication, misoprostol, 5-HT3 receptor-antagonists, antacids with magnesium or aluminum, diarrhea medication, medication that accelerates the emptying of the stomach, sulfasalazine, colestyramine, sytostats, biological medication, and probiotic products Note: medication that can be allowed if it has been consumed for at least 30 days on the same dose and is recorded during the trial include iron, antidepressants, statins, thyroxine, coxibes, acid medication (protein pump inhibitors (omeprazole, pantoprazole) and H2-blockers), inhaled steroids and other non-excluding medication that does not affect the study outcome measure in the clinicians opinion.
- •10.Diagnosed or suspected organic gastrointestinal disease (i.e. colitis, crohn’s disease, irritable bowel syndrome, celiac disease, bowel surgery, recurrent diverticulitis, megacolon, megarectum, and bowel obstruction) or severely impaired general health including cancer and cancer therapy
- •Likeliness to be noncompliant with the protocol, or to be unsuitable to the study by the investigator for any reason.
结局指标
主要结局
Change in bowel movement frequency from baseline to Day 28 (EOS) within and between treatment groups.
时间窗: 4 weeks.
次要结局
- Evaluation of food intake by 24 hour food recall at baseline and at Day 28 (EOS).(baseline and at Day 28 (EOS).)
- Change in PAC-SYM score from baseline to Day 14 and Day 28 (EOS) within and between treatment groups(2 & 4 weeks.)
- Change in stool consistency from baseline to Day 14 and Day 28 (EOS) within and between treatment groups,(2 & 4 weeks.)
- Proportion of subjects with overall product satisfaction (on a scale of 1-5) at Day 28 (EOS),(4 weeks.)
研究者
研究点 (6)
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