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

Pediococcus Acidilactici PA53 Supplementation Improves Stool Form and Modulates Gut Microbiota and Inflammatory Responses in Adults With Functional Constipation: A Randomized, Double-Blind, Placebo-Controlled Trial

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06761443

Enrollment

Registered

2025-01-07

Start date

2025-01-03

Completion date

2025-06-06

Last updated

2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

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.

Interventions

DIETARY_SUPPLEMENTProbiotic

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

DIETARY_SUPPLEMENTMaltodextrin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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. \-

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026