The Effect of Probiotics on the Improvement of Digestive Function and Well-being in the Elderly

April 15, 2025 updated by: Wecare Probiotics Co., Ltd.

Pediococcus Acidilactici on Digestive Function and Well-being in Older Adults: a Randomized, Double-blind Placebo-controlled Trial

To evaluate the effectiveness and safety of the use of probiotics as food supplements compared to placebo in improving digestive function and well-being in older adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 210095
        • Xu fei

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 1) Age is 55-70 years; 2) Willing to undergo 3 follow-up visits during the intervention period; 3) Willing to provide 2 blood, urine, and stool samples during the intervention period; 4) Willing to self-administer Pediococcus acidilactici PA53/placebo once daily during the intervention period; 5) Good eyesight, able to read and write, and can wear glasses; 6) Have good hearing and be able to hear and understand all instructions during the intervention.

Exclusion Criteria:

  • 1) Suffering from digestive disorders, mainly gastrointestinal disorders (celiac disease, ulcerative colitis, Crohn's disease); 2) Has a severe neurological condition (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, prolonged coma - excluding general anesthesia); 3) Has received/is receiving treatment for the following psychiatric disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder; 4) Take medication for depression or low mood; 5) Suffering from internal organ failure (heart, liver, or kidney failure, etc.); 6) Radiotherapy or chemotherapy in the past; 7) Surgery/procedure under general anesthesia within the past three years, or planned to undergo a procedure/procedure under general anesthesia within the next 3 months during this trial; 8) Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past; 9) Have taken Pediococcus acidilactici PA53 within the past 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic grouptics
30B CFU/strip/day PA53, before meals; Storage:Store in a cool, dry place without sun exposure.
Dietary supplement: Probiotic
The experimental phase of this study lasts 56 days and each subject will have 3 follow-up visits(d1、d28、d56).
Placebo Comparator: Placebo group
Maltodextrin, one strip/day, before meals; Storage:Store in a cool, dry place without sun exposure.
Dietary supplement: Placebo
The experimental phase of this study lasts 56 days and each subject will have 3 follow-up visits(d1、d28、d56).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in GSRS scale
Time Frame: 56 days
GSRS(Gastrointestinal Symptom Rating Scale) scale contains 13 items, each with 7 grades, from 0 to 6 indicating no symptoms, mild, mild, moderate, moderate-severe, severe, and very severe. A higher score on the GSRS scale indicates that the patient's gastrointestinal symptoms are more severe.
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wecare Probiotics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2024

Primary Completion (Actual)

December 5, 2024

Study Completion (Actual)

March 30, 2025

Study Registration Dates

First Submitted

October 16, 2024

First Submitted That Met QC Criteria

October 16, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • WK2024015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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