To Evaluate the Efficacy and Safety of Probiotics in Alleviating Constipation in Adults Through a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Improvement in bowel function
研究概览
简要总结
This randomized, double-blind, placebo-controlled trial will assess the clinical effects of probiotics in adults with functional constipation. Participants will receive probiotics or placebo for 8 weeks. The study will evaluate changes in bowel habits and symptom burden, as well as alterations in host inflammatory status, immune modulation, microbial ecosystem dynamics, neuroendocrine signaling related to the gut-brain axis, and systemic metabolic responses, to characterize the overall physiological impact of probiotic supplementation.
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
- •Men and women aged between 18 and 65 years;
- •Participants presenting with constipation, characterized by <3 spontaneous bowel movements per week or BSFS stool types 1-2;
- •Capable of following the study protocol and completing all required assessments; Individuals who have voluntarily signed the informed consent form;
- •No plans for pregnancy from at least 14 days prior to screening through 6 months after the study, with agreement to use reliable contraception methods.
排除标准
- •Intake of similar functional products within a short period prior to enrollment that could influence study results;
- •Participants who significantly alter their habitual diet during the trial;
- •Individuals with severe allergic conditions or impaired immune function;
- •Women who are pregnant, lactating, or intending to conceive;
- •Patients with serious underlying diseases affecting major organs or metabolic systems;
- •Antibiotic treatment within 2 weeks before enrollment;
- •Individuals with severe mental or psychological disorders;
- •Non-compliance with study requirements, including improper intake or missed follow-ups;
- •Other subjects considered inappropriate for participation by the investigator.
研究组 & 干预措施
Probiotic group
Participants assigned to this group will receive probiotics once daily for 8 weeks.
干预措施: Probiotics (Dietary Supplement)
Placebo group
Participants assigned to this group will receive probiotics once daily for 8 weeks.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Improvement in bowel function
时间窗: 8 weeks
Bowel function will be assessed using the Bristol Stool Form Scale (BSFS), with emphasis on the transition of stool types from harder forms (types 1-2) to softer, more normal forms (types 3-4) during the intervention period.
次要结局
未报告次要终点