Probiotic Improve Constipation

March 4, 2026 updated by: Wecare Probiotics Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Recruiting
        • Suzhou Ninth People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic Group
Taking 30 billion CFU of Lactobacillus plantarum Lp18 daily; Storage: Store in a cool, dry palce without sun expouse.
Dietary supplement: Probiotic
The experimental phase of this study had last 28 days, and each patient will make 3 visits (day 1, day 14, day 28).
Placebo Comparator: Placebo Group
Take 3g of maltodextrin daily; the product packaging is the same as that of probiotic products.
Dietary supplement: Placebo
The experimental phase of this study had last 28 days, and each patient will make 3 visits (day 1, day 14, day 28).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of constipation symptoms
Time Frame: 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).
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wecare Probiotics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WK20260305

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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