Intestinal and Immune Function Improved
Conditions
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.
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).
Sponsors
Wecare Probiotics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the concentration of LL-37 in feces before and after intervention. | Week 0 and Week 8 | Detected by Enzyme-Linked Immunosorbent Assay (ELISA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the composition of fecal microbiota before and after intervention. | Week 0 and Week 8 | Analyzed by 16s RNA sequencing. |
| Change in the concentration of calprotectin in feces before and after intervention. | Week 0 and Week 8 | Detected by Enzyme-Linked Immunosorbent Assay (ELISA). |
Countries
China
Outcome results
None listed