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NCT07462481 | RECRUITING | Constipation


Probiotic Improve Constipation
Sponsor:

Wecare Probiotics Co., Ltd.

Brief 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.

Condition or disease

Constipation

Intervention/treatment

Probiotic

Placebo

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 80 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Safety and Efficacy of Lactobacillus Plantarum in Improving Constipation: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Actual Study Start Date : 2026-04-01
Estimated Primary Completion Date : 2026-06-01
Estimated Study Completion Date : 2026-08-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • (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.
  • \-
Exclusion Criteria
  • 1. 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;
  • 2. Patients who changed their diet during the study;
  • 3. Patients with severe allergies and immunodeficiency;
  • 4. Pregnant, breastfeeding, or women planning to become pregnant;
  • 5. 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;
  • 6. Those who have used antibiotics in the past two weeks;
  • 7. Those with severe psychological or mental illnesses;
  • 8. 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;
  • 9. Other study participants deemed unsuitable by the researchers. -

Probiotic Improve Constipation

Location Details

NCT07462481


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How to Participate

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Locations


RECRUITING

China, Jiangsu

Suzhou Ninth People's Hospital

Suzhou, Jiangsu, China, 215000

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