The Effect of Probiotics on the Improvement of Intestinal and Immune Function

NCT ID: NCT06873438

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-08-15

Brief Summary

Evaluate the effectiveness and safety of Lactobacillus delbrueckii subsp. bulgaricus LB42 as a food supplement compared to a placebo in improving intestinal and immune functions in healthy adults.

Conditions

Intestinal and Immune Function Improved

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotic group

Lactobacillus delbrueckii subsp. bulgaricus LB42 (30 billion CFU/day, 3g) was administered daily for 8 weeks. Store in a cool and dry place.

Group Type: EXPERIMENTAL

Probiotic group

Intervention Type: DIETARY_SUPPLEMENT

The experimental phase of this study will last 8 weeks and each subject will receive 3 follow-up visits (week 0, week 4, week 8).

Placebo group

Every day to give 3g dextrin intervention for 8 weeks. Store in a cool and dry place.

Group Type: PLACEBO_COMPARATOR

Placebo group

Intervention Type: DIETARY_SUPPLEMENT

The experimental phase of this study will last 8 weeks and each subject will receive 3 follow-up visits (week 0, week 4, week 8).

Interventions

Probiotic group

The experimental phase of this study will last 8 weeks and each subject will receive 3 follow-up visits (week 0, week 4, week 8).

Intervention Type: DIETARY_SUPPLEMENT

Placebo group

The experimental phase of this study will last 8 weeks and each subject will receive 3 follow-up visits (week 0, week 4, week 8).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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 one of the probiotics/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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xu fei

Zhengzhou, Henan, China

Countries

China

Other Identifiers

WK20250304

Identifier Type: -

Identifier Source: org_study_id