Efficacy of Pediococcus Acidilactici as add-on to Antipsychotic Drugs on Metabolic Syndrome Disturbances in First-episode Psychosis and Schizophrenia Spectrum Disorders. A Double-blind Placebo-controlled Trial.
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Manuel Jesús Cuesta Zurita
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Metabolic Disturbances
概览
简要总结
The aim of the present study is to evaluate the effectiveness of the addition of the postbiotic Pediococcus acidilactici (pA1c®HI) on amelioration of metabolic disturbances in patients with (FEP) or (SSD) treated with antipsychotic drugs.
详细描述
This study aims to evaluate the effectiveness of an add-on postbiotic (Pediococcus acidilactici, pA1c®HI) to antipsychotic drugs on metabolic disturbances and psychopathological dimensions in patients diagnosed with first episode psychotic (FEP) or schizophrenia spectrum disorder (SSD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
A double-blind placebo-controlled trial
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PEP or TEESQ, according to DSM 5 criteria, aged between 18 and 65 years
- •Having received antipsychotic treatment for at least 8 weeks before starting the study
排除标准
- •Inability to give informed consent, lack of a representative or legal guardian capable of giving consent
- •Intellectual disability
- •Clinically significant medical condition (congestive heart failure, liver disease, renal failure, acute pancreatitis, cancer undergoing active treatment, HIV, or other immunodeficiency)
- •Active substance use in the last 3 months (except nicotine)
- •Antibiotic medication in the previous 14 days
- •Celiac disease
- •Pregnancy or breastfeeding
研究组 & 干预措施
FEP and postbiotic
Participants with FEP diagnostic taking postbiotic and atypical antipsychotics
干预措施: Pediococcus acidilactici, pA1c®HI postbiotic supplementation taking participants (Dietary Supplement)
FEP and postbiotic
Participants with FEP diagnostic taking postbiotic and atypical antipsychotics
干预措施: Atypical antipsychotics (AAP) (Drug)
SSD and postbiotic
Participants with SSD diagnostic taking postbiotic and atypical antipsychotics
干预措施: Pediococcus acidilactici, pA1c®HI postbiotic supplementation taking participants (Dietary Supplement)
SSD and postbiotic
Participants with SSD diagnostic taking postbiotic and atypical antipsychotics
干预措施: Atypical antipsychotics (AAP) (Drug)
FEP and placebo
Participants with FEP diagnostic taking placebo and atypical antipsychotics
干预措施: Atypical antipsychotics (AAP) (Drug)
SSD and placebo
Participants with SSD diagnostic taking placebo and atypical antipsychotics
干预措施: Atypical antipsychotics (AAP) (Drug)
结局指标
主要结局
Metabolic Disturbances
时间窗: Beginning (week 0) and end of the study (week 12).
1\. Total cholesterol Description: Measurement of total cholesterol in the blood. Includes LDL, HDL, and other fractions. It is a general marker of cardiovascular risk. Units: mg/dL Ranges: Desirable: \< 200 mg/dL High limit: 200-239 mg/dL High: ≥ 240 mg/dL
Metabolic Disturbances
时间窗: Beginning (week 0) and end of the study (week 12)
2\. LDL cholesterol (Low-Density Lipoprotein) Description: Known as "bad cholesterol." High levels are associated with atherosclerosis and cardiovascular disease. Units: mg/dL Ranges: Optimal: \< 100 mg/dL Near optimal: 100-129 mg/dL High limit: 130-159 mg/dL High: 160-189 mg/dL Very high: ≥ 190 mg/dL
次要结局
- Clinical Measures(Along the study: week 0, week 6, and week 12)
- Clinical measures(Along the study: week 0, week 6, and week 12)
- Anthropometric Parameters(Along the study: week 0, week 6, and week 12.)
- Anthropometric Parameters(Along the study: week 0, week 6, and week 12)
研究者
Manuel Jesús Cuesta Zurita
PSYCHIATRIST
Fundacion Miguel Servet