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

NCT06594406 | Completed

• 1 other identifier: zhujiangjy-0108
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Hamilton Depression Rating Scale

  Comparison of Hamilton Depression Rating Scale before and after treatment

  4 weeks

Secondary Outcomes (1)

• Change from baseline in creatine level in blood

  4 weeks

Study Arms (4)

Healthy individuals with creatine

EXPERIMENTAL

Dietary Supplement: Creatine

Healthy individuals with creatine and bifidobacterium

EXPERIMENTAL

Dietary Supplement: Bifidobacterium and creatine

Depression individuals with placebo

PLACEBO COMPARATOR

Depressed individuals with placebo and antidepressants

Dietary Supplement: Placebo

Depression individuals with creatine and bifidobacterium

EXPERIMENTAL

Depression individuals with creatine and bifidobacterium and antidepressants

Dietary Supplement: Bifidobacterium and creatine

Interventions

Creatine DIETARY_SUPPLEMENT

The dosing schedule of creatine administration is 3 g daily for 4 weeks, and administration of a placebo.

Healthy individuals with creatine

Bifidobacterium and creatine DIETARY_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.

Depression individuals with creatine and bifidobacterium; Healthy individuals with creatine and bifidobacterium

Placebo DIETARY_SUPPLEMENT

Administration of creatine placebo and bifidobacterium placebo for 4 weeks,

Depression individuals with placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Southern medical university

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Depression

Interventions

Creatine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Xiong Cao, Doctor

  Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: September 19, 2024
• Study Start: October 10, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 27, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)