Healthy
Conditions
Brief summary
Evaluate the effectiveness and safety of Bifidobacterium longum subsp. infantis BI45 as a food supplement compared to a placebo in improving intestinal and immune functions in healthy adults.
Interventions
DIETARY_SUPPLEMENTProbiotic
Dietary supplement: Probiotics. The trial period of this study lasts for 2 months (8 weeks), during which each participant will have 3 visits (at month 0, month 1, and month 2).
DIETARY_SUPPLEMENTPlacebo
Dietary supplement: Placebo. The trial period of this study lasts for 2 months (8 weeks), during which each participant will have 3 visits (at month 0, month 1, and month 2).
Sponsors
Wecare Probiotics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Willing to undergo 3 follow-up visits during the intervention period Be willing to provide blood, urine and stool samples 2 times during the intervention period 2. Willing to self-administer probiotic or placebo once a day during the intervention period 3. Good eyesight, can read and write, can wear glasses 4. Have good hearing and be able to hear and understand all instructions during the intervention
Exclusion criteria
1. Digestive diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease) 2. Have a serious neurological condition (epilepsy, stroke, severe head trauma, meningitis in the last 10 years, brain surgery, brain tumor, prolonged coma - not including general anaesthesia) 3. Have received/are receiving treatment for the following mental disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder 4. Take medication for depression or low mood Internal organ failure (heart, liver or kidney failure, etc.) 5. Have received radiation or chemotherapy in the past 6. Have undergone a general anesthesia procedure/procedure within the past three years, or plan to undergo a general anesthesia procedure/procedure within the next 3 months during this trial period 7. 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 antimicrobial peptides (LL-37 and 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