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

NCT ID: NCT06594406

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-10
• Study Completion Date: 2025-06-27

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Healthy individuals with creatine

Group Type: EXPERIMENTAL

Creatine

Intervention Type: DIETARY_SUPPLEMENT

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

Healthy individuals with creatine and bifidobacterium

Group Type: EXPERIMENTAL

Bifidobacterium and creatine

Intervention Type: 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 placebo

Depressed individuals with placebo and antidepressants

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Administration of creatine placebo and bifidobacterium placebo for 4 weeks,

Depression individuals with creatine and bifidobacterium

Depression individuals with creatine and bifidobacterium and antidepressants

Group Type: EXPERIMENTAL

Bifidobacterium and creatine

Intervention Type: 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.

Interventions

Creatine

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

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Administration of creatine placebo and bifidobacterium placebo for 4 weeks,

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yan He

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiong Cao, Doctor

Role: PRINCIPAL_INVESTIGATOR

Southern Medical University

Locations

Southern medical university

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

zhujiangjy-0108

Identifier Type: -

Identifier Source: org_study_id