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

W

Wecare Probiotics

Status

Not yet enrolling

Conditions

Adults Aged 18-45 Years

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Probiotic

Study type

Interventional

Funder types

Industry

Identifiers

NCT06779994
WK2025002

Details and patient eligibility

About

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

Enrollment

90 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 2 patient groups, including a placebo group

Probiotic group
Experimental group
Description:
30B CFU/strip/day ST36, before meals; Storage: Store in a cool, dry place without sun exposure.
Treatment:
Dietary Supplement: Probiotic
Placebo group
Placebo Comparator group
Description:
Maltodextrin, one strip/day, before meals; Storage: Store in a cool, dry place without sun exposure.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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