NCT07462494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
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Changes in stool consistency
研究概览
简要总结
To evaluate the effects of probiotic intervention on gastrointestinal function in patients with constipation after 4 weeks of treatment, and to explore its potential effects on immune status and bone metabolism.
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
- •Aged 18-65 years.
- •Patients with constipation, defined as fewer than three bowel movements per week and/or Bristol Stool Form Scale (BSFS) types 1-
- •Able to comply with the study protocol and complete the study procedures.
- •Participants who have voluntarily signed the informed consent form.
- •Participants (including male participants) must have no plans for pregnancy from 14 days before screening until 6 months after the end of the study and must agree to use effective contraception during this period.
排除标准
- •Individuals who have recently taken products with similar functions to the investigational product that may affect the evaluation of study outcomes.
- •Participants who plan to change their dietary habits during the study period.
- •Patients with severe allergies or immunodeficiency.
- •Women who are pregnant, breastfeeding, or planning to become pregnant.
- •Patients with severe diseases of major organs such as the cardiovascular system, lungs, liver, or kidneys, or those with severe metabolic diseases (e.g., diabetes or thyroid disorders), malignant tumors, or severe immune system diseases.
- •Individuals who have used antibiotics within the past two weeks.
- •Individuals with severe psychological or psychiatric disorders.
- •Participants who fail to take the investigational product as required or fail to attend scheduled follow-up visits, resulting in an inability to determine treatment efficacy.
- •Any other participants considered unsuitable for participation in the study by the investigator.
研究组 & 干预措施
Placebo group
Placebo Comparator
Maltodextrin powder administered orally once daily for 8 weeks.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes in stool consistency
时间窗: 4 weeks
Stool consistency will be evaluated using the Bristol Stool Form Scale (BSFS) to assess the improvement of constipation symptoms in patients receiving probiotic intervention.
次要结局
未报告次要终点
研究者
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