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

NCT ID: NCT06648590

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-20
• Study Completion Date: 2025-03-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotic grouptics

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

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Probiotic

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 55 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

Xu fei

Zhengzhou, Henan, China

Countries

China

Other Identifiers

WK2024015

Identifier Type: -

Identifier Source: org_study_id