RecruitingNot ApplicableNCT07462481

Probiotic Improve Constipation

Safety and Efficacy of Lactobacillus Plantarum in Improving Constipation: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Sponsor

Wecare Probiotics Co., Ltd.

Enrollment

80 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Constipation

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

(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.
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Exclusion Criteria9

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. -

Interventions

DIETARY_SUPPLEMENTProbiotic

The experimental phase of this study had last 28 days, and each patient will make 3 visits (day 1, day 14, day 28).

DIETARY_SUPPLEMENTPlacebo

The experimental phase of this study had last 28 days, and each patient will make 3 visits (day 1, day 14, day 28).

Locations(1)

Suzhou Ninth People's Hospital

Suzhou, Jiangsu, China

View Full Details on ClinicalTrials.gov

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NCT07462481

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