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Recruiting

NCT Number: NCT07462481

Probiotic Improve Constipation

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suzhou Ninth People's Hospital

Suzhou, Jiangsu, 215000, China

Location status: Recruiting

Location contact

Ying Jin, Doctor

CONTACT

[email protected]

18336086291

Who can participate

Healthy volunteers accepted: Yes

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

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.

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Exclusion criteria

  • 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. -

Treatment and study plan

Probiotic

Dietary Supplement

The intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8.

Placebo

Dietary Supplement

The intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8.

High-activity probiotic probiotic

Dietary Supplement

The intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8.

Primary outcomes

  1. Improvement of constipation symptoms

    Time frame: 8 weeks

    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).

Study contacts

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

Ying Jin

CONTACT

[email protected]

18336086291

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Probiotics in Relieving Constipation in Adults

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
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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