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

NCT ID: NCT06761443

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-25
• Study Completion Date: 2025-05-25

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.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Probiotic

Every day to Pediococcus acidilactici PA53 (30 billion CFU/day, 3g) intervention, for 8 weeks.

Store in a cool and dry place.

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

The experimental phase of this study had last 8 weeks and each patient will make 3 visits (week 0, week 4, week 8).

Placebo

Every day to give 3 g maltodextrin intervention for 8 weeks. Store in a cool and dry place.

Group Type: PLACEBO_COMPARATOR

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

The experimental phase of this study had last 8 weeks and each patient will make 3 visits (week 0, week 4, week 8).

Interventions

Probiotic

The experimental phase of this study had last 8 weeks and each patient will make 3 visits (week 0, week 4, week 8).

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

The experimental phase of this study had last 8 weeks and each patient will make 3 visits (week 0, week 4, week 8).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

-

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. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Nutrition, General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuhan xia, Doctor

Role: CONTACT

1959643812@qq.com

18336086291

Facility Contacts

Yuhan xia, Doctor

Role: primary

1959643812@qq.com

18336086291

Other Identifiers

WK2024018

Identifier Type: -

Identifier Source: org_study_id