Status:
NOT_YET_RECRUITING
Research on the Role of Probiotics in Human Intestinal Health
Lead Sponsor:
Wecare Probiotics Co., Ltd.
Conditions:
Intestinal Microbiota
Eligibility:
All Genders
18-45 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Willing to attend 3 follow-up visits during the intervention period
- Agree to provide blood, urine, and stool samples twice during the intervention period
- Good eyesight, able to read and write, and capable of wearing glasses if needed
- Good hearing and able to fully comprehend all instructions during the intervention
Exclusion
- Presence of digestive diseases, particularly gastrointestinal disorders (e.g., celiac disease, ulcerative colitis, Crohn's disease)
- 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)
- History of or currently receiving treatment for mental health disorders such as alcohol/drug/substance abuse, schizophrenia, psychosis, or bipolar disorder
- Currently taking medication for depression or low mood
- Presence of internal organ failure (e.g., heart, liver, or kidney failure)
- History of radiation therapy or chemotherapy treatments
- Underwent general anesthesia within the past three years or are scheduled for general anesthesia within the next 3 months during the trial period
- History of hepatitis (B or C), HIV, or syphilis
Key Trial Info
Start Date :
March 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06886711
Start Date
March 10 2025
End Date
December 30 2025
Last Update
March 20 2025
Active Locations (1)
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1
Henan University of Technology
Zhengzhou, Henan, China, 210095