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

NCT06779994 | Completed

• 1 other identifier: WK2025002
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adults Aged 18-45 Years

Outcome Measures

Primary Outcomes (1)

• Antimicrobial peptide levels in stool samples

  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.

  8 weeks

Study Arms (2)

Probiotic group

EXPERIMENTAL

30B CFU/strip/day ST36, before meals; Storage: Store in a cool, dry place without sun exposure.

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

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).

Probiotic group

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).

Placebo group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) 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;

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Xu fei

Zhengzhou, Henan, 210095, China

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double(Participant, investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 17, 2025
• Study Start: April 10, 2025
• Primary Completion: May 6, 2025
• Study Completion: August 20, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

CN (1)