跳至主要内容
临床试验/NCT03552237
NCT03552237Unknown不适用

The Effect of Dietary Fiber Supplement on the Intestinal Microbiota Among Schizophrenia Patients With Central Obesity: a Pilot Study

TsaoTun Psychiatric Center, Department of Health, Taiwan0 个研究点目标入组 40 人开始时间: 2018年6月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
主要终点
Changes from baseline in microbiota composition at week 4

研究概览

简要总结

Background There has been much interest in the relationship between the types of gut microbiota and the development of obesity in recent years. It has been reported that the proportions of Firmicutes and Bacteroidetes differ between obese and normal weight human subjects. Human intestinal microbiota compositions have been found to be associated with long-term dietary habits and lifestyle. However, an increasing number of researches show that intestinal microbiota composition may be affected after short-term diet intervention. Importantly, obesity and metabolic problems play important roles in morbidity and mortality of schizophrenia patients. Human intestinal microbiota compositions related with obesity may impact the heath of this population. Therefore, we searched current advances about the connection of obesity, intestinal microbiota compositions, and diet in schizophrenia to conduct a clinical research focus on the effect of high fiber diet on the intestinal microbiota of schizophrenia patients with central obesity.

Method We will investigate in a 4-week intervention whether consumption of dietary fiber supplement(Inulin) affect the microbiota composition in schizophrenia inpatients with central obesity. Fecal samples from participants before and after the intervention will be processed for the microbiota analysis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Schizophrenia inpatients
  • Overweight and with central obesity
  • agree to sign informed consent

排除标准

  • Diagnosis of IBS
  • Systemic antibiotic use during the past 4 weeks
  • Excessive water intake

研究组 & 干预措施

dietary fiber intervention group

Experimental

干预措施: dietary fiber (Dietary Supplement)

结局指标

主要结局

Changes from baseline in microbiota composition at week 4

时间窗: 4 weeks

Fecal samples from participants before and after the intervention will be processed for microbiota analysis

次要结局

未报告次要终点

研究者

发起方
TsaoTun Psychiatric Center, Department of Health, Taiwan
申办方类型
Other
责任方
Principal Investigator
主要研究者

C Lin

Director of General Psychiatry Department

TsaoTun Psychiatric Center, Department of Health, Taiwan

相似试验

Effect of Dietary Fiber Supplement on the Intestinal... | 临床试验