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

Wecare Probiotics

Status: Enrolling

Conditions: Constipation

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Maltodextrin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06761443

WK2024018

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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. -

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

Every day to Pediococcus acidilactici PA53 (30 billion CFU/day, 3g) intervention, for 8 weeks. Store in a cool and dry place.

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Maltodextrin