CompletedNot Applicable

To Evaluate the Safety and Efficacy of Pediococcus Acidilactici PA53 in Relieving Constipation in Adults

China87 participantsStarted 2025-01-03

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: (1) age 18-70 years; (2) fewer than three SBMs per week and/or BSFS type 1 or 2; (3) ability to comply with study requirements; (4) provision of signed informed consent; (5) for participants of childbearing potential (including both sexes), agreement to use effective contraception from 14 days before screening until 6 months after study completion. \- Exclusion Criteria: (1) consumption of food or drugs known to affect gastrointestinal function (e.g., laxatives, probiotics) within 4 weeks prior to enrollment; (2) a change in dietary habits within the past month or planned during the study; (3) pregnancy, lactation, or intention to become pregnant; (4) history of severe cardiovascular, pulmonary, hepatic, renal, metabolic (e.g., diabetes, thyroid disease), malignant, or immunological disorders; (5) antibiotic use within 4 weeks prior to the study; (6) severe psychiatric illness; (7) any other condition deemed by the investigators to make the participant unsuitable for the trial. \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Constipation symptom improvement

Timeframe: 8 weeks

Trial details

NCT IDNCT06761443

SponsorWecare Probiotics Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-03

View on ClinicalTrials.gov More Constipation trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.