Effect of Bifidobacterium on Creatine Absorption in Adults with Depression
Therapeutic Effects of Oral Bifidobacterium on Depression by Promoting Exogenous Creatine Absorption
This study is testing if taking Bifidobacterium with creatine can help adults with depression feel better compared to taking creatine alone or a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06594406 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether Bifidobacterium can enhance the antidepressant effects of creatine in adults diagnosed with major depressive disorder. Participants will take either Bifidobacterium combined with creatine, creatine alone, or a placebo daily for four weeks. Throughout the study, they will maintain a diary of their symptoms and provide blood samples for analysis. The primary focus is to determine if the combination of Bifidobacterium and creatine leads to improved absorption and better outcomes in depression treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with a current diagnosis of major depressive disorder and a Hamilton Depression Scale score greater than 16.
Not a fit: Patients with bipolar disorder, schizophrenia, or those at serious suicide risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel approach to enhancing antidepressant effects in patients with major depression.
How similar studies have performed: While the combination of probiotics and antidepressants is an emerging area, this specific approach has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Guangzhou, Guangdong
- Southern medical university — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Xiong Cao, Doctor — Southern Medical University
- Study coordinator: Xiong Cao, Doctor
- Email: caoxiong@smu.edu.cn
- Phone: 13929532753
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.