The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation: Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Improvement in quality of life
研究概览
简要总结
This study aimed to investigate the relationship between administration of probiotics and improvement in quality of life in women with functional constipation.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being declared healthy based on initial examination and the Structured Interview Questionnaire (SIQ)
- •Having the symptoms and signs of functional constipation refer to ROME IV
- •Able to communicate well
- •Able to consume 1 bottle of fermented milk each day for three weeks
- •Not using antibiotic no later than one week before supplementation
排除标准
- •Diagnosed with functional bowel disorder
- •Using anesthesia at least 4 weeks before treatment
- •Having a serious pathological disorder (carcinoma)
- •During healing phase of acute gastrointestinal disorders at least 4 weeks before treatment
- •Having severe heart disease
- •Taking chronic medications such as antidepressants or analgesics
研究组 & 干预措施
Probiotic
Lactobacillus plantarum IS-10506
干预措施: Lactobacillus plantarum IS-10506 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in quality of life
时间窗: Three weeks after intervention.
Improvement in quality of life were assessed using PAC-QOL© (Patient Assessment of Constipation - Quality of Life) questionnaire, consisting of four domains: physical discomfort, psychosocial discomfort, worries/concerns, and satisfaction. * Physical discomfort, minimum score 0, maximum score 16, lower value represents better outcome * Psychosocial discomfort, minimum score 0, maximum score 32, lower value represents better outcome * Worries/concerns, minimum score 0, maximum score 44, lower value represents better outcome * Satisfaction, minimum score 0, maximum score 20, higher value represents better outcome Total score = physical discomfort + psychosocial discomfort + worries/concerns - satisfaction • Total score, minimum score -20, maximum score 92, lower value represents better outcome
次要结局
未报告次要终点
研究者
Murdani Abdullah
Clinical Professor
Fakultas Kedokteran Universitas Indonesia