Study on the Effect of Probiotics on Improving Gastrointestinal Function in Patients With Non-organic Gastrointestinal Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Improvement of gastrointestinal function in study participants
研究概览
简要总结
To verify the improvement of gastrointestinal function in patients with non-organic gastrointestinal dysfunction after 4 weeks of intervention with compound probiotics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Voluntarily sign the informed consent form and agree to participate in the study.
- •Ability to complete the study according to the trial protocol requirements.
- •Aged 18-65 years.
- •Clinical diagnosis of non-organic gastrointestinal dysfunction (e.g., functional dyspepsia, functional constipation) without other serious organic diseases.
排除标准
- •Use of drugs affecting intestinal flora (antibiotics, probiotics, intestinal mucosal protectants, herbal medicines, etc.) for >1 week within 1 month prior to screening.
- •Short-term use of products with functions similar to the investigational product, which may interfere with result interpretation.
- •Antibiotic use during the study period.
- •History of severe systemic diseases or malignancies.
- •Allergy to any ingredient in the compound probiotic freeze-dried powder used in the trial.
- •Pregnancy, lactation, or plans for pregnancy in the near future.
- •Inability to participate due to personal reasons.
- •Other conditions deemed unsuitable by the investigators.
结局指标
主要结局
Improvement of gastrointestinal function in study participants
时间窗: 4 weeks
The severity of gastrointestinal symptoms was assessed by the Gastrointestinal Symptom Rating Scale (GSRS). Each item is scored from 1 (no symptoms) to 7 (extremely severe symptoms. Higher scores indicate worse gastrointestinal dysfunction.
Improvement of gastrointestinal function in study participants
时间窗: 4 weeks
The severity of gastrointestinal symptoms was assessed by the Gastrointestinal Symptom Rating Scale (GSRS). Each item is scored from 1 (no symptoms) to 7 (extremely severe symptoms. Higher scores indicate worse gastrointestinal dysfunction.
次要结局
未报告次要终点