Safety and Efficacy of Probiotics for Constipation Relief in Adults: A Randonmized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Improvement of constipation symptoms
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled trial in which adult subjects with constipation are randomly assigned to either a probiotic group or a placebo group for an 8-week intervention. Through blood and fecal sample analyses combined with multidimensional questionnaire assessments, the study aims to systematically evaluate the efficacy of probiotics in improving gastrointestinal function, immune status, and mental health in patients with constipation.
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
- Double (Participant, Investigator)
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 to 65 years (inclusive).
- •Diagnosed with constipation, defined as fewer than 3 spontaneous bowel movements per week and/or Bristol Stool Form Scale types 1 or
- •Willing and able to comply with the study protocol and complete all required assessments.
- •Provide written informed consent prior to any study-related procedures.
- •Male and female participants of childbearing potential must agree to use effective contraception voluntarily from 14 days prior to screening until 6 months after the end of the trial. Female participants of non-childbearing potential (e.g., post-menopausal or surgically sterile) are exempt from this requirement.
排除标准
- •Use of products with functions similar to the investigational product within a short period prior to screening that may interfere with the evaluation of study outcomes.
- •Intention to change dietary habits significantly during the study period.
- •Severe allergies or immunodeficiency.
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the trial.
- •Severe diseases of vital organs (including cardiovascular, pulmonary, hepatic, or renal disease), metabolic diseases (e.g., diabetes, thyroid disorders), malignancy, or severe immune system disorders.
- •Use of antibiotics within the past 30 days.
- •Severe psychological or psychiatric disorders.
- •Poor compliance (e.g., failure to take the test product as instructed or failure to attend scheduled follow-up visits) that would preclude a valid assessment of efficacy.
- •Organic constipation (e.g., caused by structural or pathological conditions).
- •Irritable bowel syndrome with constipation (IBS-C).
- •History of surgical procedures within 30 days prior to screening that may have caused or contributed to constipation symptoms.
- •Intake of probiotic or prebiotic supplements within one month prior to the start of the study.
- •Any other condition that, in the investigator's opinion, would make the participant unsuitable for participation in the study.
研究组 & 干预措施
Probiotics Group
Participants receive one sachet (1g) of probiotic powder containing 2.0 × 10¹⁰ CFU per sachet, taken orally once daily for 8 weeks.
干预措施: Probitics (Dietary Supplement)
Placebo Group
Matching placebo powder (maltodextrin), identical in appearance, taste, and weight to the probiotic powder, administered orally once daily for 8 weeks.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Improvement of constipation symptoms
时间窗: Baseline, Week 1, Week 2, Week 4, Week 8
Improvement in constipation was assessed using the Bristol Stool Characteristics Scale (BSFS), primarily observing the shift in stool type from type 1-2 (hard stool/constipation) to type 3-4 (normal/ideal soft stool).
Change in Spontaneous Bowel Movement (SBM) Frequency
时间窗: Baseline, Week 1, Week 2, Week 4, Week 8
Change from baseline in number of spontaneous bowel movements. Spontaneous bowel movements are defined as bowel movements occurring without the use of laxatives, enemas, or suppositories within the previous 24 hours.
次要结局
- Change in Serum Digestive Enzyme Levels(Baseline, Week 8)
- Change in Gastrointestinal Symptom Rating Scale (GSRS) Score(Baseline, Week 1, Week 2, Week 4, Week 8)
- Change in Patient Assessment of Constipation Symptoms (PAC-SYM) Score(Baseline, Week 1, Week 2, Week 4, Week 8)
- Change in Patient Assessment of Constipation Quality of Life (PAC-QOL) Score(Baseline, Week 1, Week 2, Week 4, Week 8)
- Change in Depression, Anxiety, and Stress Scale-21 (DASS-21) Score(Baseline, Week 1, Week 2, Week 4, Week 8)
- Change in Serum Inflammatory and Immune Markers(Baseline, Week 8)
- Change in Serum Gut-Brain Axis Regulatory Markers(Baseline, Week 8)
- Change in Serum Intestinal Barrier Function Markers(Baseline, Week 8)
- Change in Gut Microbiota Composition(Baseline, Week 8)