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

NCT06648590 | Completed

• 1 other identifier: WK2024015
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

People Aged 55-70 Years

Outcome Measures

Primary Outcomes (1)

• Change in GSRS scale

  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

Study Arms (2)

Probiotic grouptics

EXPERIMENTAL

30B CFU/strip/day PA53, before meals; Storage:Store in a cool, dry place without sun exposure.

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

Maltodextrin, one strip/day, before meals; Storage:Store in a cool, dry place without sun exposure.

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

The experimental phase of this study lasts 56 days and each subject will have 3 follow-up visits(d1、d28、d56).

Probiotic grouptics

Placebo DIETARY_SUPPLEMENT

The experimental phase of this study lasts 56 days and each subject will have 3 follow-up visits(d1、d28、d56).

Placebo group

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Xu fei

Zhengzhou, Henan, 210095, China

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: October 20, 2024
• Primary Completion: December 5, 2024
• Study Completion: March 30, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

CN (1)