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临床试验/NCT07032857
NCT07032857招募中不适用

Breaking Barriers: A Clinical Experimental Study of Intestinal Permeability in Children With Autism Spectrum Disorder

University of Bari1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2023年1月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
55
试验地点
1
主要终点
intestinal permeability

研究概览

简要总结

In recent years, increasing attention has been directed toward the role of the gut-brain axis in the pathogenesis of neurodevelopmental disorders, particularly Autism Spectrum Disorder (ASD). Among the multiple contributing factors, the integrity of the intestinal barrier appears to play a crucial role. Enhanced paracellular permeability ("leaky gut") may allow luminal antigens and microbial metabolites to translocate into the systemic circulation, triggering inflammatory responses that could impact neuropsychological functioning.

Several studies suggest that, although intestinal permeability is not universally altered in all individuals with ASD, there exists a subset characterized by selective epithelial dysfunction, especially associated with repetitive and stereotyped behaviors.

This project aims to investigate, through a controlled sibling-based design, whether intestinal permeability indices are significantly altered in children with ASD and whether such alterations are specifically correlated with behavioral domains assessed through the ADOS instrument.

详细描述

Study Objectives

Primary Objective:

• To compare intestinal permeability profiles in children with ASD and their neurotypical siblings, using the La/Ma ratio and the recovery of specific sugars (lactulose, mannitol, sucrose, sucralose).

Secondary Objectives:

  • To explore the correlations between intestinal permeability markers and behavioral dimensions assessed via ADOS, with particular focus on stereotyped behaviors and communication.
  • To assess the presence of intestinal inflammation through fecal calprotectin (FC) measurement.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
2 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Known neurological disorders.
  • Major congenital anomalies.
  • Severe head trauma.
  • Chronic gastrointestinal diseases.
  • Special diets (e.g., gluten-free or gluten/casein-free).
  • Antibiotic or probiotic/prebiotic intake in the previous 4 weeks.

结局指标

主要结局

intestinal permeability

时间窗: baseline

La/Ma ratio and the recovery of specific sugars (lactulose, mannitol, sucrose, sucralose).

次要结局

未报告次要终点

研究者

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

Ruggiero Francavilla

Prof

University of Bari

研究点 (1)

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