The Effect of Lactobacillus Reuteri Supplementation to Adult With Functional Chronic Constipation: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The increase of BMs/week frequency
研究概览
简要总结
A double-blind, placebo Randomized Controlled Trial, To evaluate the effects of L. reuteri in adult patients with functional constipation.
详细描述
Patients affected by functional constipation according to Rome III criteria. The increase of Bowel Movements/week frequency was the primary outcome, while the improvement of stool consistency was the secondary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •functional constipation rome III
排除标准
- •hypothyroidism or other metabolic or renal abnormalities, or
- •antibiotic's treatment,
- •probiotic or prebiotic supplementation in the last month
研究组 & 干预措施
lactobacillus reuteri
Intervention: supplementation with the probiotic Lactobacillus reuteri (DSM 17938),Reuflor, was administered in the dose of 108 colony-forming units (CFU) in tablets of a commercially available preparation (Reuflor, Italchimici, Pomezia; BioGaia AB, Stockholm, Sweden), 30 minutes after feeding, twice per day for 4 weeks.
干预措施: lactobacillus reuteri (Drug)
placebo
a supplementation with placebo was administered in tablets of a commercially available preparation 30 minutes after feeding, twice per day for 4 weeks
干预措施: placebo (Drug)
结局指标
主要结局
The increase of BMs/week frequency
时间窗: January to June 2012 (up to 6 months)
次要结局
- the improvement of stool consistency(january to june 2012 (up to 6 months))
研究者
veronica ojetti
adjunt professor
Catholic University, Italy