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

NCT06873438 | Completed

• 1 other identifier: WK20250304
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in the concentration of LL-37 in feces before and after intervention.

  Detected by Enzyme-Linked Immunosorbent Assay (ELISA).

  Week 0 and Week 8

Secondary Outcomes (2)

• Change in the composition of fecal microbiota before and after intervention.

  Week 0 and Week 8

• Change in the concentration of calprotectin in feces before and after intervention.

  Week 0 and Week 8

Study Arms (2)

Probiotic group

EXPERIMENTAL

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

Dietary Supplement: Probiotic group

Placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo group

Interventions

Probiotic group 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).

Probiotic group

Placebo group 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

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
• Willing to undergo 3 follow-up visits during the intervention period
• Willing to provide 2 blood, urine, and stool samples during the intervention period
• Willing to self-administer one of the probiotics/placebo once daily during the intervention period
• Good eyesight, able to read and write, and can wear glasses
• 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)
• 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)
• Has received/is receiving treatment for the following psychiatric disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder
• Take medication for depression or low mood
• Suffering from internal organ failure (heart, liver, or kidney failure, etc.)
• Radiotherapy or chemotherapy in the past
• 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
• 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

Study Design

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

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 12, 2025
• Study Start: March 1, 2025
• Primary Completion: May 25, 2025
• Study Completion: August 15, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

CN (1)