DepressionNCT06594406
The Effect of Oral Bifidobacterium on Exogenous Creatine Absorption in Adult Subjects
A study testing Creatine and Bifidobacterium and creatine in people with Depression, run by Zhujiang Hospital at 1 site in China.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Creatine and Bifidobacterium and creatine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2024to 27 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Probiotics use in last 30 days
- Positive pregnancy test
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Depression
- Being tested
- Creatine, Bifidobacterium and creatine, Placebo
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreatineDietary supplement
The dosing schedule of creatine administration is 3 g daily for 4 weeks, and administration of a placebo.
Bifidobacterium and creatineDietary 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.
PlaceboDietary supplement
Administration of creatine placebo and bifidobacterium placebo for 4 weeks,
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals with creatine | Experimental | Not described Receives: Dietary Supplement: Creatine |
| Healthy individuals with creatine and bifidobacterium | Experimental | Not described Receives: Dietary Supplement: Bifidobacterium and creatine |
| Depression individuals with placebo | Placebo comparator | Depressed individuals with placebo and antidepressants Receives: Dietary Supplement: Placebo |
| Depression individuals with creatine and bifidobacterium | Experimental | Depression individuals with creatine and bifidobacterium and antidepressants Receives: Dietary Supplement: Bifidobacterium and creatine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Hamilton Depression Rating Scale
Comparison of Hamilton Depression Rating Scale before and after treatment
Measured: 4 weeks
Secondary outcomes (1)
Change from baseline in creatine level in blood
Comparison of creatine level in blood before and after treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Oct 2024
- Primary completion30 May 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan He, Zhujiang Hospital
- Investigators
- Xiong Cao, Doctor, Principal investigator, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594406
- Sponsor's protocol ID
- zhujiangjy-0108
- Status last verified
- Jul 2025
- First submitted
- 6 Aug 2024
- Last updated
- 3 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effects of Combining Bifidobacterium With Creatine on Depression
- ClinicalTrials.gov ID
- NCT06594406
- Acronym / sponsor ID
- zhujiangjy-0108
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: PlaceboDepressed individuals with placebo and antidepressants |
| Depression individuals with creatine and bifidobacterium | Experimental | Dietary Supplement: Bifidobacterium and creatineDepression individuals with creatine and bifidobacterium and antidepressants |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CreatineThe dosing schedule of creatine administration is 3 g daily for 4 weeks, and administration of a placebo. | Dietary supplement | Healthy individuals with creatine |
| Bifidobacterium and creatineThe 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. | Dietary supplement | Depression individuals with creatine and bifidobacterium, Healthy individuals with creatine and bifidobacterium |
| PlaceboAdministration of creatine placebo and bifidobacterium placebo for 4 weeks, | Dietary supplement | Depression individuals with placebo |
Primary outcome
Change from Baseline in Hamilton Depression Rating Scale
Time frame: 4 weeks
Comparison of Hamilton Depression Rating Scale before and after treatment
1 secondary outcome
Change from baseline in creatine level in blood
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiong Cao, Doctor principal investigator
Southern Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine and Bifidobacterium and creatine in people with Depression, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Hamilton Depression Rating Scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.