The Safety and Efficacy of Probiotic for Improving Intestinal and Immune Function

Not Applicable

Not yet recruiting

• Conditions: Adults Aged 18-45 Years

• Registration Number: NCT06779994
• Lead Sponsor: Wecare Probiotics Co., Ltd.

Brief Summary

To evaluate the safety and efficacy of Streptococcus salivarius subsp. thermophilus ST36 in healthy adults on immune function and intestinal health.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-14
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Study Start: 2025-02-10
• Primary Completion: 2025-04-10
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 1. Age 18-45 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 Streptococcus salivarius subsp. thermophilus ST36/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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Antimicrobial peptide levels in stool samples	8 weeks	Antimicrobial peptides refer to fecal calprotectin and LL-37(Cathelicidin Antimicrobial Peptide). The change in their concentrations at the end of the intervention was detected compared to baseline.