Effect of a Synbiotic on Symptoms of Patients With Slow Transit Constipation: A Prospective Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical remission rate
研究概览
简要总结
To evaluate the efficacy of synbiotic (BIFICOPEC) containing Enterococci, Bifidobacteria, Lactobacilli triple viable bacteria and pectin in patients with slow transit constipation.
详细描述
Chronic constipation has become a common, often chronic, functional gastrointestinal disease which influences the quality of life all over the world. A total of 100 patients diagnosed as slow transit constipation (STC) using Rome III criteria were randomized to receive either synbiotic or placebo twice daily for 12 weeks. The primary efficacy endpoint was the clinical remission and improvement rate at week 4 and 12. Stool frequency and consistency, colonic transit time (CTT), evacuation and abdominal symptoms, Patient Assessment of Constipation Symptoms (PAC-SYM scores), Gastrointestinal Quality-of-Life Index (GIQLI), Satisfaction scores and adverse events were also monitored.
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
- Single (Participant)
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
- •age ≥ 18 years;
- •BMI: 18.5-25kg/m2;
- •chronic constipation was diagnosed according to RomeⅢ criteria;
- •colonic transit time (CTT) >48 hours;
- •mild-to-moderate constipation with wexner constipation scale between 16 and 25.
排除标准
- •megacolon, intestinal obstruction, inflammatory bowel disease, and cancer;
- •secondary constipation (i.e. drugs, endocrine disorders, neurological disorders, metabolic disorders, psychological disorders or abdominal surgery);
- •severe anterior rectocele or full thickness rectorectal intussusception according to defecography;
- •pregnant or lactating women;
- •infection with enteric pathogen;
- •usage of antibiotics or proton pump inhibitors (PPIs);
- •hepatic, renal, cardiovascular, respiratory or psychiatric disease;
- •other diseases or factors evaluated by the investigator which could influence intestinal transit or intestinal microbiota.
研究组 & 干预措施
Placebo
patients allowed to take maltodextrin by the experienced doctor.
干预措施: maltodextrin (Drug)
synbiotic
patients are allowed to take synbiotic (BIFICOPEC) contained 0.63g bifid triple viable capsule (BIFICO) and 8g soluble dietary fiber (Pectin) .
干预措施: bifid triple viable capsule and pectin (Drug)
结局指标
主要结局
Clinical remission rate
时间窗: 3 months
Patients having an average of three or more spontaneous complete bowel movements (SCBMs) per week were defined as remission.
Clinical improvement rate
时间窗: 3 months
Patients with an average increase of one or more spontaneous complete bowel movements (SCBMs) per week were defined as improvement.
次要结局
- Number of bowel movements per week(3 months)
- Stool consistency according to the Bristol Stool Form Scale (BSFS)(3 months)
- Colonic transit time (CTT)(3 months)
- Evacuation symptoms(3 months)
- Treatment-related adverse events(3 months)
- Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire(3 months)
- Satisfaction score of constipated patients(3 months)
- The Gastrointestinal Quality-of-Life Index (GIQLI)(3 months)
- Abdominal symptoms(3 months)
研究者
Jianfeng Gong
Professor
Jinling Hospital, China