Completed

NCT Number: NCT06873438

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intestinal and Immune Function Improved

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xu fei

Zhengzhou, Henan, 210095, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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).

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).

Primary outcomes

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).

Secondary outcomes

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

Time frame: Week 0 and Week 8

Analyzed by 16s RNA sequencing.
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).

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Mar 12, 2025
Registry last updated: Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.