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

The Therapeutic Effects of Combining Bifidobacterium With Creatine on Depression

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 Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Creatine; Dietary supplement: Bifidobacterium and creatine

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy individuals with creatine	Dietary supplement: Creatine; The dosing schedule of creatine administration is 3 g daily for 4 weeks, and administration of a placebo.
Experimental: Healthy individuals with creatine and bifidobacterium	Dietary supplement: Bifidobacterium and creatine; 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.
Placebo Comparator: Depression individuals with placebo; Depressed individuals with placebo and antidepressants	Dietary supplement: Placebo; Administration of creatine placebo and bifidobacterium placebo for 4 weeks,
Experimental: Depression individuals with creatine and bifidobacterium; Depression individuals with creatine and bifidobacterium and antidepressants	Dietary supplement: Bifidobacterium and creatine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Hamilton Depression Rating Scale	Comparison of Hamilton Depression Rating Scale before and after treatment	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in creatine level in blood	Comparison of creatine level in blood before and after treatment	4 weeks

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Investigators: Principal Investigator: Xiong Cao, Doctor, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): June 27, 2025

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: September 10, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: zhujiangjy-0108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No