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OpenTrials
Completed

NCT Number: NCT06779994

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

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xu fei

Zhengzhou, Henan, 210095, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic

Dietary Supplement

The experimental phase of this study will last 8 weeks and each subject will have three visits (day 0, week 4 and week 8).

Placebo

Dietary Supplement

The experimental phase of this study will last 8 weeks and each subject will have three visits (day 0, week 4 and week 8).

Primary outcomes

  1. Antimicrobial peptide levels in stool samples

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

Safety and Efficacy of Streptococcus Salivarius Subsp. Thermophilus ST36 on Intestinal and Immune Function Improvement.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.