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

September 29, 2025 updated by: Wecare Probiotics Co., Ltd.

A Study on the Safety and Effectiveness of Lactobacillus Delbrueckii Subsp. Bulgaricus LB42 in Improving Intestinal and Immune Functions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 210095
        • Xu fei

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: 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).
Placebo Comparator: Placebo group
Every day to give 3g dextrin intervention for 8 weeks. Store in a cool and dry place.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the concentration of LL-37 in feces before and after intervention.
Time Frame: Week 0 and Week 8
Detected by Enzyme-Linked Immunosorbent Assay (ELISA).
Week 0 and Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the composition of fecal microbiota before and after intervention.
Time Frame: Week 0 and Week 8
Analyzed by 16s RNA sequencing.
Week 0 and Week 8
Change in the concentration of calprotectin in feces before and after intervention.
Time Frame: Week 0 and Week 8
Detected by Enzyme-Linked Immunosorbent Assay (ELISA).
Week 0 and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wecare Probiotics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Actual)

May 25, 2025

Study Completion (Actual)

August 15, 2025

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 12, 2025

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • WK20250304

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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