Status:
COMPLETED
The Effect of Oral Bifidobacterium on Exogenous Creatine Absorption in Adult Subjects
Lead Sponsor:
Zhujiang Hospital
Conditions:
Depression
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The purpose of this clinical trial is to learn if Bifidobacterium has antidepressant-like effects by enhancing creatine absorption in adults. The main questions to be answered are Does Bifidobacteriu...
Eligibility Criteria
Inclusion
- Inclusion Criteria for depression:
- Adults age 18-60 years inclusive.
- Current diagnosis of major depression disorder (MDD) identified by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (SCID-5).
- Current Hamilton Depression Scale 17 score of \> 16.
- BMI (body Mass Index) between 18 and 28 kg/m²
- Right-handed
- Exclusion Criteria:
- Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the SCID-5.
- History of or current diagnosis of acute kidney injury (AKI), chronic kidney disease (CKD) or end-stage renal disease (ESRD)
- History of seizure disorder
- Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale
- Previous diagnosis of creatine deficiency syndrome or evidence of creatine deficiency syndrome
- Antibiotic use in last 30 days
- Probiotics use in last 30 days
- Positive pregnancy test
- Breastfeeding
Exclusion
Key Trial Info
Start Date :
October 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2025
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT06594406
Start Date
October 10 2024
End Date
June 27 2025
Last Update
August 3 2025
Active Locations (1)
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1
Southern medical university
Guangzhou, Guangdong, China, 510515