NCT07462481招募中不适用
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Probiotics in Relieving Constipation in Adults
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Improvement of constipation symptoms
研究概览
简要总结
To evaluate the efficacy and safety of probiotic as a food supplement in regulating bowel habits in patients with chronic constipation, and to compare it with placebo.
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
- •(1) Age 18-65 years; (2) Constipated patients (less than 3 bowel movements per week and/or Bristol Scale type 1 and 2); (3) Able to complete the study according to the trial protocol; (4) Patients who have signed the informed consent form; (5) Study participants (including male study participants) have no plans to have children within 14 days prior to screening and within 6 months after the end of the trial and voluntarily use effective contraception.
排除标准
- •Those who have taken a substance with a similar function to the test subject in a short period of time, affecting their judgment of the results;
- •Patients who changed their diet during the study;
- •Patients with severe allergies and immunodeficiency;
- •Pregnant, breastfeeding, or women planning to become pregnant;
- •Those with severe diseases of vital organs such as the cardiovascular system, lungs, liver, and kidneys, diabetes, thyroid disease, severe metabolic diseases, malignant tumors, or severe immune system diseases;
- •Those who have used antibiotics in the past two weeks;
- •Those with severe psychological or mental illnesses;
- •Those who did not consume the test sample as required or did not follow up on time, resulting in the inability to determine the efficacy;
- •Other study participants deemed unsuitable by the researchers. -
研究组 & 干预措施
Probiotic Group
Experimental
Taking 30 billion CFU of Lactobacillus plantarum Lp18 daily; Storage: Store in a cool, dry palce without sun expouse.
干预措施: Probiotic (Dietary Supplement)
Placebo Group
Placebo Comparator
Take 3g of maltodextrin daily; the product packaging is the same as that of probiotic products.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Improvement of constipation symptoms
时间窗: 28 days
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).
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Lactiplantibacillus Plantarum 299v Probiotic Supplementation in Patients With Diabetic Macular EdemaNCT07383701Massachusetts Eye and Ear Infirmary36
尚未招募
3 期
Effect of nutritional supplement in obesityCTRI/2024/04/065821Seven Turns Pvt Ltd100
已完成
1 期
Evaluating the capacity of probiotic chewable tablets containing probiotic bacteria on halitosis enzyme levels in patients with bad breath as an adjunct totooth cleaning –a randomized control trial study.CTRI/2025/03/082544Lakshmi C40
尚未招募
2 期
The Effect of Probiotics on Gut Microbiota Changes in Healthy Chinese Adults During Short-Term European Travel: A Randomised, Double-Blind, Placebo-Controlled Clinical TrialNCT07384260Min-Tze LIONG40
招募中
不适用
Effect of use of Lactobacillus plantarum UBLP-40 in addition iron supplement on anemia in pregnant womenCTRI/2024/09/073839Unique Biotech240