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临床试验/NCT05688618
NCT05688618招募中不适用

Effect of the Administration of a Symbiotic (E. Faecium and Agave Inulin) on Mild Cognitive Impairment in Older Adults

Anahuac University2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年11月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
48
试验地点
2
主要终点
Cognitive impairment

研究概览

简要总结

Cognitive impairment is one of the fastest growing diseases in the last decades, given the significant increase in senior citizen population in Mexico and the world.

Several studies have discussed the gut-microbiota-brain axis. It has been demonstrated that a balanced gut microbiota, prevents an increase in pro-inflammatory cytokines that affect specific brain areas; having an important impact at the cortical level of the hippocampus which translates to diminished cognitive function and the start of cognitive impairment symptoms.

After multiple studies on the effect of the administration of symbiotics in animal models in cognition and memory, there have been positive results, observing improvement in cognition and decrement in inflammatory cytokines at hippocampus level.

详细描述

Cognitive impairment is one of the fastest growing diseases in the last decades, given the significant increase in senior citizen population in Mexico and the world.

Cognitive impairment is the loss of cognitive functions, in the abscence of other pathologies that may be the cause of the memory loss. It is well known that this pathology can progress to more severe states reaching irreversible dementia such as Alzheimer in a short period of approximately 5 years from the onset of the disease.

Given the rapid increase in incidence of cognitive impairment, there have been several studies on the management of symptoms and on the natural course of the disease.

Several studies have discussed the gut-microbiota-brain axis. It has been demonstrated that a balanced gut microbiota, prevents an increase in pro-inflammatory cytokines that affect specific brain areas; having an important impact at the cortical level of the hippocampus which translates to diminished cognitive function and the start of cognitive impairment symptoms.

After multiple studies on the effect of the administration of symbiotics in animal models in cognition and memory, there have been positive results, observing improvement in cognition and decrement in inflammatory cytokines at hippocampus level.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
70 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with mild cognitive impairment
  • Patients who sign the informed consent

排除标准

  • Patients who do not have mild cognitive impairment
  • Patients with advanced cognitive impairment such as Alzheimers disease
  • Patients with comorbidities that influence the cognitive functions such as diabetes mellitus, cerebral ischemia or previous brain trauma
  • Patients who do not sign the informed consent

结局指标

主要结局

Cognitive impairment

时间窗: 8 weeks

Change in Score for Mini mental state examination

次要结局

未报告次要终点

研究者

发起方
Anahuac University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose Juan Antonio Ibarra Arias

Responsable

Anahuac University

研究点 (2)

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