Based on a Randomized, Double-blind, Placebo-controlled Trial, we Evaluated the Safety and Efficacy of Pediococcus Acidilactici PA53 in Relieving Constipation in Adults

Wecare Probiotics Co., Ltd.1 site in 1 country10 target enrollmentFebruary 25, 2025

ConditionsConstipation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Constipation
Sponsor: Wecare Probiotics Co., Ltd.
Enrollment: 10
Locations: 1
Primary Endpoint: Constipation symptom improvement
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To study the improvement of constipation symptoms, quality of life and mental state, intestinal function, intestinal hormones, inflammation and immunity, and intestinal flora of constipation subjects after 8-week intervention with Pediococcus acidilactici PA53.

Registry

clinicaltrials.gov

Start Date

February 25, 2025

End Date

May 25, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wecare Probiotics Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Constipated subjects Subjects (less than 3 bowel movements per week and/or Bristol Scale Types 1 and 2);
•Be able to complete the research according to the requirements of the test plan;
•Subjects who have signed informed consent;
•Subjects (including male subjects) have no family planning and voluntarily take effective contraceptive measures from 14 days before screening to 6 months after the end of the trial.

Exclusion Criteria

•Short-term use of items with similar functions to the subject, which affects the judge of the result;
•Those who changed their diet type during the study period;
•People with severe allergies and immune deficiencies;
•Women who are pregnant, breastfeeding or planning to become pregnant;
•Patients with serious diseases of cardiovascular, lung, liver, kidney and other vital organs, diabetes, thyroid disease, severe metabolic diseases, malignant tumors, and severe immune system diseases;
•People who have used antibiotics in the past two weeks;
•People with serious mental and mental illness;
•Failure to eat the test sample as required, or failure to follow up on time, resulting in uncertain efficacy;
•Other researchers judged it inappropriate to participate. -

Outcomes

Primary Outcomes

Constipation symptom improvement

Time Frame: 8 weeks

Assessing the improvement of constipation in patients using the Bristol Stool Form Scale (BSFS) . In this scale, higher scores indicate softer stool textures, closer to liquid consistency. Scores of 4, 5, and 6 are generally considered ideal stool characteristics.