The Therapeutic Effects of Combining Bifidobacterium With Creatine on Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Change from Baseline in Hamilton Depression Rating Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 >
- •BMI (body Mass Index) between 18 and 28 kg/m²
- •Right-handed
排除标准
- •Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the SCID-
- •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
研究组 & 干预措施
Healthy individuals with creatine and bifidobacterium
干预措施: Bifidobacterium and creatine (Dietary Supplement)
Depression individuals with placebo
Depressed individuals with placebo and antidepressants
干预措施: Placebo (Dietary Supplement)
Depression individuals with creatine and bifidobacterium
Depression individuals with creatine and bifidobacterium and antidepressants
干预措施: Bifidobacterium and creatine (Dietary Supplement)
Healthy individuals with creatine
干预措施: Creatine (Dietary Supplement)
结局指标
主要结局
Change from Baseline in Hamilton Depression Rating Scale
时间窗: 4 weeks
Comparison of Hamilton Depression Rating Scale before and after treatment
Change from Baseline in Hamilton Depression Rating Scale
时间窗: 4 weeks
Comparison of Hamilton Depression Rating Scale before and after treatment
次要结局
- Change from baseline in creatine level in blood(4 weeks)
- Change from baseline in creatine level in blood(4 weeks)
研究者
Yan He
Professor
Zhujiang Hospital