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NCT Number: NCT07462494

Probiotic Intervention in Constipation

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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Exclusion criteria

  • Individuals who have recently taken products with similar functions to the investigational product that may affect the evaluation of study outcomes.
  • Participants who plan to change their dietary habits during the study period.
  • Patients with severe allergies or immunodeficiency.
  • Women who are pregnant, breastfeeding, or planning to become pregnant.
  • 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.
  • Individuals who have used antibiotics within the past two weeks.
  • Individuals with severe psychological or psychiatric disorders.
  • 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.
  • Any other participants considered unsuitable for participation in the study by the investigator.

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Treatment and study plan

GUT99 1

Dietary Supplement

Taken orally once daily for 8 weeks (120B).

Placebo

Dietary Supplement

Taken orally once daily for 8 weeks.

GUT99 2

Dietary Supplement

Taken orally once daily for 8 weeks (1000B).

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Jin, Doctor

CONTACT

[email protected]

13375163966

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

To Evaluate the Efficacy and Safety of Probiotics in Alleviating Constipation in Adults Through a Randomized, Double-blind, Placebo-controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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