Probiotic Intervention in Constipation

March 27, 2026 updated by: Wecare Probiotics Co., Ltd.

Clinical Study of Probiotic Intervention in Patients With Constipation: Evaluation of Gastrointestinal Function, Immunity, and Bone Metabolism

To evaluate the effects of probiotic intervention on gastrointestinal function in patients with constipation after 4 weeks of treatment, and to explore its potential effects on immune status and bone metabolism.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

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

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. Aged 18-65 years.
  2. Patients with constipation, defined as fewer than three bowel movements per week and/or Bristol Stool Form Scale (BSFS) types 1-2.
  3. Able to comply with the study protocol and complete the study procedures.
  4. Participants who have voluntarily signed the informed consent form.

  5. Participants (including male participants) must have no plans for pregnancy from 14 days before screening until 6 months after the end of the study and must agree to use effective contraception during this period.

    -

Exclusion Criteria:

  1. Individuals who have recently taken products with similar functions to the investigational product that may affect the evaluation of study outcomes.
  2. Participants who plan to change their dietary habits during the study period.
  3. Patients with severe allergies or immunodeficiency.
  4. Women who are pregnant, breastfeeding, or planning to become pregnant.
  5. Patients with severe diseases of major organs such as the cardiovascular system, lungs, liver, or kidneys, or those with severe metabolic diseases (e.g., diabetes or thyroid disorders), malignant tumors, or severe immune system diseases.
  6. Individuals who have used antibiotics within the past two weeks.
  7. Individuals with severe psychological or psychiatric disorders.
  8. Participants who fail to take the investigational product as required or fail to attend scheduled follow-up visits, resulting in an inability to determine treatment efficacy.

  9. Any other participants considered unsuitable for participation in the study by the investigator.

    -

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic group A
Probiotic powder containing GUT99 (1000B) administered orally once daily for 8 weeks.
Dietary supplement: GUT99 1
Taken orally once daily for 8 weeks (120B).
Placebo Comparator: Placebo group
Maltodextrin powder administered orally once daily for 8 weeks.
Dietary supplement: Placebo
Taken orally once daily for 8 weeks.
Experimental: Probiotic group B
Probiotic powder containing GUT99 (120B) administered orally once daily for 8 weeks.
Dietary supplement: GUT99 2
Taken orally once daily for 8 weeks (1000B).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in stool consistency
Time Frame: 8 weeks
Stool consistency will be evaluated using the Bristol Stool Form Scale (BSFS) to assess the improvement of constipation symptoms in patients receiving probiotic intervention.
8 weeks

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)

December 1, 2026

Study Completion (Estimated)

December 30, 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)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • WK20260304

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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