The Effect of Oral Bifidobacterium on Exogenous Creatine Absorption in Adult Subjects

Zhujiang Hospital77 enrolled

Overview

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 Bifidobacterium combined with creatine have better antidepressant effects? Does Bifidobacterium enhance exogenous creatine uptake? Researchers will compare bifidobacterium combined with creatine with placebo to see if bifidobacterium combined with creatine has antidepressant effects. Participants will: Take bifidobacterium, creatine or placebo every day for 4 weeks. Keep a diary of their symptoms and collect blood samples.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Depression

Interventions

Creatine

Bifidobacterium and creatineDIETARY_SUPPLEMENT

The dosing schedule of creatine administration is 3 g daily for 4 weeks. In parallel, the dosing schedule of bifidobacterium administration is 200 million colony-forming units (CFU) /day for 4 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from Baseline in Hamilton Depression Rating Scale

Comparison of Hamilton Depression Rating Scale before and after treatment

Time frame: 4 weeks

Secondary Outcomes

Change from baseline in creatine level in blood

Comparison of creatine level in blood before and after treatment