People Aged 55-70 Years
Conditions
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
The experimental phase of this study lasts 56 days and each subject will have 3 follow-up visits(d1、d28、d56).
DIETARY_SUPPLEMENTPlacebo
The experimental phase of this study lasts 56 days and each subject will have 3 follow-up visits(d1、d28、d56).
Sponsors
Wecare Probiotics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in GSRS scale | 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. |
Countries
China
Outcome results
None listed