Effects of 4-week Bifidobacterium Lactis HN019 Supplementation on Whole Gut Transit Time and Gastrointestinal Symptoms in Adults With Constipation: A Double-blind, Randomized, Placebo-controlled Dose-ranging Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 224
- 试验地点
- 22
- 主要终点
- Whole Gut Transit Time
研究概览
简要总结
This study will investigate the effects of 4-week probiotic supplementation on whole gut transit time and gastrointestinal symptoms in adults with functional constipation.
详细描述
This prospective, double-blind, randomized, placebo-controlled clinical trial will investigate the effects of 4-week B. lactis HN019 supplementation on whole gut transit time and gastrointestinal symptoms in adults with functional constipation. Participants who meet all study entry criteria will enter a 2-week run-in period. Following successful completion of the run-in period, subjects will be randomized to 4-week supplementation with B. lactis HN019 (10 billion cfu), B. lactis HN019 (1 billion cfu), or placebo. The primary outcome of whole gut transit time will be evaluated with abdominal x-rays on days 0 and 28. Secondary outcomes include IBS-specific questionnaires (administered on days 0 and 28); abdominal pain severity, bowel movement frequency, stool consistency, and adverse events (evaluated daily throughout the study); and overall product satisfaction (evaluated at day 28). Physical activity questionnaires and 24-hour food recalls will be completed periodically during the trial.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years
- •Body mass index between 18.5 and 34.9 kg/m2
- •Self-reported unsatisfactory defecation due to infrequent stools and/or difficult stool passage, which includes at least one of the following: symptoms of straining, difficulty expelling stool, a sense of incomplete evacuation, hard or lumpy stools, prolonged time to stool, or a need for manual maneuvers to pass stool.
- •Estimated stool consistency < 4.0 on BSSF (self-reported at screening) within the past month prior to enrollment.
- •Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects
- •Consent to the study and willing to comply with study product and methods
排除标准
- •Major gastrointestinal complication (e.g. Crohn's disease, ulcer)
- •Prior abdominal surgery that, in the opinion of the investigator, may present a risk for the subject or confound study results
- •Clinically significant underlying systemic illness that may preclude the subject's ability to complete the trial or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness)
- •Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2 weeks of screening and throughout the trial other than the provided study products
- •Non-laxative constipation medication use within 2 weeks of screening, laxative use within 48 hours of screening (rescue medication allowed for intolerable symptoms during study)
- •Daily use of anticholinergic agents, opioid analgesics, calcium supplements, calcium-channel blockers, and NSAIDs
- •Anticipated major dietary or exercise changes during the study
- •Systemic steroid use
- •Eating disorder
- •Contraindication to dairy products (e.g., intolerance to lactose or any substance in the study product)
- •History of alcohol, drug, or medication abuse
- •Pregnant or lactating female, or pregnancy planned during study period
- •Participation in another study with any investigational product within 30 days of screening
- •Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study
结局指标
主要结局
Whole Gut Transit Time
时间窗: 4 weeks
The primary endpoint of this clinical trial is whole gut transit time, which will be assessed using abdominal x-rays on days 0 and 28
次要结局
- Patient Assessment of Constipation QoL (PAC-QoL)(4 weeks)
- Bowel Movement Frequency(4 weeks)
- Stool Consistency(4 weeks)
- Patient Assessment of Constipation Symptoms (PAC-SYM)(4 weeks)
- Adequate Relief of Constipation (Yes/no)(4 weeks)
- Bowel Function Index(4 weeks)
- Overall Product Satisfaction(4 weeks)
- Adverse Event Frequency(4 weeks)