CClinicalTrials.gg
Sign In
CompletedNCT06873438Updated Oct 3, 2025

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

An interventional study of Probiotic group and Placebo group in Intestinal and Immune Function Improved, sponsored by Wecare Probiotics Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-03.

Sponsored by Wecare Probiotics Co., Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Intestinal and Immune Function Improved
03

In context

Lead sponsor

Wecare Probiotics Co., Ltd. is the lead sponsor of 65 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
52 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Dietary supplementProbiotic 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).

  • Dietary supplementPlacebo 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).

06

What researchers measure

Primary outcomes

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

    Detected by Enzyme-Linked Immunosorbent Assay (ELISA).

    Time frame: Week 0 and Week 8

Secondary outcomes

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

    Analyzed by 16s RNA sequencing.

    Time frame: Week 0 and Week 8

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

    Detected by Enzyme-Linked Immunosorbent Assay (ELISA).

    Time frame: Week 0 and Week 8

07

Study locations

1 site
  • Xu fei
    Zhengzhou, Henan 210095, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06873438
Lead sponsor
Wecare Probiotics Co., Ltd.
Responsible party
Sponsor
First posted
Mar 12, 2025
Start date
Mar 1, 2025
Primary completion
May 25, 2025
Completion
Aug 15, 2025
Last update
Oct 3, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Wecare Probiotics Co., Ltd.

Start the discussion