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OpenTrials
Completed

NCT Number: NCT06594406

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southern medical university

Guangzhou, Guangdong, 510515, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Creatine

Dietary Supplement

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

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.

Placebo

Dietary Supplement

Administration of creatine placebo and bifidobacterium placebo for 4 weeks,

Primary outcomes

  1. Change from Baseline in Hamilton Depression Rating Scale

    Time frame: 4 weeks

    Comparison of Hamilton Depression Rating Scale before and after treatment

Secondary outcomes

  1. Change from baseline in creatine level in blood

    Time frame: 4 weeks

    Comparison of creatine level in blood before and after treatment

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Official study title

The Therapeutic Effects of Combining Bifidobacterium With Creatine on Depression

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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