Mesalazine and/or Lactobacillus Casei in Maintaining Remission of Symptomatic Uncomplicated Diverticular Disease of the Colon: a Double-blind, Double-dummy, Placebo-controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 14
- 主要终点
- Number of patients maintaining remission of symptomatic uncomplicated diverticular disease of the colon
研究概览
简要总结
This is a multi-centre, randomised, double blind, double-dummy, parallel groups, placebo-controlled trial was conducted in a population of patients suffering from symptomatic uncomplicated diverticular disease in order to investigate which is the best treatment in preventing relapses of the disease.
Patients were randomly divided in double-blind fashion in one of the following groups:
Group A. Active mesalazine 800 mg, 2 tablets/day for 10 days/month plus Lactobacillus casei placebo, 1 sachet/day for 10 days/month;
Group B. Active Lactobacillus casei, 1 sachet/day for 10 days/month plus mesalazine 800 placebo, 2 tablets/day for 10 days/month;
Group C. Active mesalazine 800 ng, 2 tablets/day plus Active Lactobacillus casei, 1 sachet/day for 10 days/month;
Group D. Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month.
The main objective was to assess the safety and the efficacy of mesalazine and/or Lactobacillus casei in maintaining remission of symptomatic uncomplicated diverticular disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of diverticular disease diagnosed for the first time or established by previous colonoscopy
- •symptomatic episode of uncomplicated diverticular disease no more than 4 weeks prior to study entry
- •patients who have given their free and informed consent.
排除标准
- •acute diverticulitis (both complicated and uncomplicated)
- •diverticular colitis
- •active or recent peptic ulcer
- •chronic renal insufficiency
- •allergy to salicylates
- •patients with intended or ascertained pregnancy, lactation
- •women of childbearing age not using contraceptives
- •lactulose-lactitol use in the two weeks before the enrolment and during the study
- •presence of diverticulitis complications (fistulas, abscesses, and/or stenoses)
- •use of probiotic preparations either prescribed or over-the counter within two weeks prior to study entry
- •inability to give a valid informed consent or to properly follow the protocol
- •patients with active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment were also acceptable)
- •recent history or suspicion of alcohol abuse or drug addiction
- •any severe pathology that can interfere with the treatment or the clinical or instrumental tests of the trial
- •use of NSAIDS for one week before and throughout the study period (only paracetamol was permitted).
研究组 & 干预措施
Mesalazine
Active mesalazine 800 mg, 2 tablets/day for 10 days/month plus Lactobacillus casei placebo, 1 sachet/day for 10 days/month.
干预措施: Mesalazine 800 mg (Drug)
Lactobacillus casei
Active Lactobacillus casei, 1 sachet/day for 10 days/month plus mesalazine 800 mg placebo, 2 tablets/day for 10 days/month.
干预措施: Lactobacillus casei (Drug)
Mesalazine plus Lactobacillus casei
Active mesalazine 800 mg, 2 tablets/day plus active Lactobacillus casi, 1 sachet/day for 10 days/month.
干预措施: Mesalazine plus Lactobacillus casei (Drug)
Placebo
Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month.
干预措施: Mesalazine placebo plus Lactobacillus casei placebo (Drug)
结局指标
主要结局
Number of patients maintaining remission of symptomatic uncomplicated diverticular disease of the colon
时间窗: one year
次要结局
- Safety of the treatments(one year)
- Influence of severity of diverticulosis on number of patients maintaining remission of symptomatic diverticular disease of the colon(one year)
- Concomitant diseases(one year)
研究者
Giovanni Brandimarte
MD; PhD
Hospital Cristo Re