NCT07507955尚未招募不适用
To Evaluate the Efficacy and Safety of Probiotics in Alleviating Constipation in Adults Through a Randomized, Double-blind, Placebo-controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 105
- 试验地点
- 1
研究概览
简要总结
This study aims to evaluate the efficacy and safety of Bifidobacterium animalis subsp. lactis BLa36 in adults with functional constipation. In this randomized, double-blind, placebo-controlled trial, participants will receive BLa36 supplementation or placebo for 8 weeks. Clinical outcomes will be assessed using validated gastrointestinal symptom scales, stool characteristics, and quality-of-life measures. In addition, changes in inflammatory and immune markers, gut microbiota composition, metabolic indicators, and gut-brain axis-related parameters will be evaluated to comprehensively determine the effects of BLa36 on intestinal function and overall health.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-65 years;
- •Individuals diagnosed with constipation, defined as fewer than 3 bowel movements per week and/or Bristol Stool Form Scale (BSFS) types 1-2;
- •Able and willing to comply with all study procedures and complete the study;
- •Provided written informed consent prior to participation;
- •Participants (including males) must have no intention of conception from 14 days before screening until 6 months after study completion and agree to use effective contraception.
排除标准
- •Recent use of products with similar effects that may interfere with study outcomes; Significant dietary changes during the study period;
- •History of severe allergy or immunodeficiency;
- •Pregnant or breastfeeding women, or those planning pregnancy;
- •Presence of serious systemic diseases (e.g., cardiovascular, pulmonary, hepatic, renal, endocrine, or malignant conditions);
- •Use of antibiotics within the past 2 weeks;
- •Individuals with severe psychiatric or neurological disorders;
- •Poor compliance, including failure to take the study product or attend scheduled visits;
- •Any other condition deemed unsuitable by the investigator.
研究者
研究点 (1)
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