Intestinal Microbiota
Conditions
Keywords
Probiotics, Intestinal Barrier Function
Brief summary
Evaluate the efectiveness and safety of Bifidobacterium bifidum BBi32 as a food supplement compared to a placebo in improving intestinal andimmune functions in healthy adults.
Interventions
DIETARY_SUPPLEMENTProbiotic
Dietary supplement: Probiotics. The trial period of this study lasts for 2 months(8weeks), during which each participant will have 3 visits (at month 0, month 1, andmonth 2).
DIETARY_SUPPLEMENTPlacebo
Dietary supplement: Placebo. The trial period of this study lasts for 2 months(8weeks), during which each participant will have 3 visits (at month 0, month 1, andmonth 2).
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. Willing to attend 3 follow-up visits during the intervention period 2. Agree to provide blood, urine, and stool samples twice during the intervention period 3. Good eyesight, able to read and write, and capable of wearing glasses if needed 4. Good hearing and able to fully comprehend all instructions during the intervention
Exclusion criteria
1. Presence of digestive diseases, particularly gastrointestinal disorders (e.g., celiac disease, ulcerative colitis, Crohn's disease) 2. History of serious neurological conditions (e.g., epilepsy, stroke, severe head trauma, meningitis within the last 10 years, brain surgery, brain tumor, or prolonged coma-not including general anesthesia) 3. History of or currently receiving treatment for mental health disorders such as alcohol/drug/substance abuse, schizophrenia, psychosis, or bipolar disorder 4. Currently taking medication for depression or low mood 5. Presence of internal organ failure (e.g., heart, liver, or kidney failure) 6. History of radiation therapy or chemotherapy treatments 7. Underwent general anesthesia within the past three years or are scheduled for general anesthesia within the next 3 months during the trial period 8. History of hepatitis (B or C), HIV, or syphilis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fecal Microbiota Composition Before and After Intervention | Baseline (Week 0) and post-intervention (Week 8) | Fecal microbiota composition will be analyzed using 16S rRNA gene sequencing to assess taxonomic and relative abundance changes. |
Countries
China
Contacts
Primary ContactXu Fei Doctor
Outcome results
None listed