A Double Blind Placebo-Controlled Study on the Effect of the Probiotic Lactobacillus Gasseri DSM 27123 on Functional Constipation in Healthy Women - Proof of Concept
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioGaia AB
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in frequency of complete spontaneous bowel movements (CSBMs)
研究概览
简要总结
The primary objective is to determine the change in frequency of complete spontaneous bowel movements (CSBMs) after 4 weeks of oral supplementation with Lactobacillus gasseri DSM 27123 in healthy adult women with functional constipation.
详细描述
Subjects to complete study diaries, number of SBM, CSBM, form of faeces (according to the Bristol Stool Form scale), pain during defecation (according to the visual analogue scale [VAS] 0-100), time spent at each evacuation, episodes of faecal incontinence, number of ingested capsules of investigational product will be recorded daily by the subjects
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 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The subjects have to meet all of the following criteria to be eligible to enter the study:
- •Willing and able to provide informed consent
- •Women aged 18-49 years at Visit 1
- •BMI ≥18 and ≤29 at Visit 1
- •Suffering of functional constipation as defined by the Rome III criteria for functional constipation
- •Comply with the requirement not to use any other probiotic products from Visit 1 and throughout the study period
- •Not pregnant or breastfeeding
- •Using adequate contraceptive measures
- •Ability to understand and comply with the requirements of the study, as judged by the Investigator
排除标准
- •Hypersensitivity or allergy to the investigational product, to chemically related products or to comparator/placebo
- •Well-known, organic cause of constipation
- •Anorectal pathology
- •Previous gastrointestinal surgery
- •Any alarming symptoms (i.e. rectal bleeding, weight loss, jaundice) as judged by the Investigator
- •Spinal anomalies and injuries
- •Use of antibiotics within 4 weeks prior to Visit 1
- •Use of products containing probiotics more than once a week in the previous 3 weeks
- •Mental or behavioural disorders as judged by the Investigator
- •Food allergy
研究组 & 干预措施
Lactobacillus gasseri
Lactobacillus gasseri DSM 27123 capsules, 1×109 CFU (divided in two doses)
干预措施: Lactobacillus gasseri DSM 27123 (Dietary Supplement)
Placebo
Placebo capsules (two doses)
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in frequency of complete spontaneous bowel movements (CSBMs)
时间窗: Baseline and 4 weeks
次要结局
- Proportion of responders(4 weeks)
- Number of participants with treatement related adverse events(During the whole study - 4 weeks)
- Need for laxative medication(During the treatment period - 4 weeks)
- Presence of Lactobacillus gasseri DSM 27123 in faeces(4 weeks)
- Change in Stool Consistency (Bristol Stool Form scale)(Baseline, week 1, 2, 3 and 4)
- Change in Patient-Assessment of Constipation Symptoms (PAC-SYM)(Baseline, week 1, 2, 3 and 4 (change from baseline))
- Change in Gastrointestinal Symptom Rating Scale (GSRS)(Baseline, week 1, 2, 3 and 4)