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

Not Applicable

Recruiting

• Conditions: Constipation

• Registration Number: NCT06761443
• Lead Sponsor: Wecare Probiotics Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-01
• Study First Submitted QC: 2025-01-01
• Last Update Submitted: 2025-01-01
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Study Start: 2025-02-25
• Primary Completion: 2025-04-25
• Study Completion: 2025-05-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Constipated subjects Subjects (less than 3 bowel movements per week and/or Bristol Scale Types 1 and 2); 2. Be able to complete the research according to the requirements of the test plan; 3. Subjects who have signed informed consent; 4. 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.

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Exclusion Criteria

1. Short-term use of items with similar functions to the subject, which affects the judge of the result;
2. Those who changed their diet type during the study period;
3. People with severe allergies and immune deficiencies;
4. Women who are pregnant, breastfeeding or planning to become pregnant;
5. 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;
6. People who have used antibiotics in the past two weeks;
7. People with serious mental and mental illness;
8. Failure to eat the test sample as required, or failure to follow up on time, resulting in uncertain efficacy;
9. Other researchers judged it inappropriate to participate. -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Constipation symptom improvement	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.

Trial Locations

Locations (1)

Department of Nutrition, General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, Ningxia, China