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

Not Applicable

Recruiting

• Conditions: Depression
• Interventions: Dietary Supplement: Bifidobacterium; Dietary Supplement: Placebo; Dietary Supplement: creatine; Dietary Supplement: Bifidobacterium and creatine

• Registration Number: NCT06594406
• Lead Sponsor: Zhujiang Hospital

Brief Summary

The purpose of this clinical trial is to learn if Bifidobacterium has better 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 to creatine or bifidobacterium to see if bifidobacterium combined with creatine has better antidepressant effects.

Participants will:

Take bifidobacterium, creatine or placebo every day for 4 weeks. Keep a diary of their symptoms and collect blood samples.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-09-10
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Study Start: 2024-10-10
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-08-01
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Depression individuals with bifidobacterium	Bifidobacterium	Depression individuals with bifidobacterium and antidepressants
Healthy individuals with placebo	Placebo	-
Healthy individuals with bifidobacterium	Bifidobacterium	-
Healthy individuals with creatine	creatine	-
Healthy individuals with creatine and bifidobacterium	Bifidobacterium and creatine	-
Depression individuals with placebo	Placebo	Depressed individuals with placebo and antidepressants
Depression individuals with creatine	creatine	Depressed individuals with creatine and antidepressants
Depression individuals with creatine and bifidobacterium	Bifidobacterium and creatine	Depression individuals with creatine and bifidobacterium and antidepressants

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Hamilton Depression Rating Scale	4 weeks	Comparison of Hamilton Depression Rating Scale before and after taking creatine or bifidobacterium

Secondary Outcome Measures

Name	Time	Method
Change from baseline in creatine level in blood	4 weeks	Comparison of creatine level in blood before and after taking creatine or bifidobacterium

Trial Locations

Locations (1)

Southern medical university; 🇨🇳 Guangzhou, Guangdong, China