Mycobiome Evaluation in Children With Autism & GI Symptoms
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fecal Mycobiome Composition as assessed by sequencing of fecal fungal species
研究概览
简要总结
This study's primary aim is to explore the potential differences in the gut mycobiome of children with autism spectrum disorder compared to otherwise healthy children. The secondary objective of this study is to evaluate whether the presence of specific species of fungi (e.g. Candida tropicalis, C. albicans, or Saccharomyces cerevisiae), in stool: 1) correlates with increased gastrointestinal symptoms; 2) correlates with evidence of increased behavioral problems (as assessed by the Aberrant Behavior Checklist or Social Responsiveness Scale-2); or 3) plays the same role as a constituent of commensal gut microflora as in normal controls. The scale indicates severity of social deficits in the autism spectrum as mild, moderate or severe. Additionally, the study aims to compare the fecal and oral fungi in these children because many fecal mycobiota are felt to originate in the oropharynx.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for autistic children with GI symptoms: confirmed diagnosis of autism spectrum disorder (ASD) and its severity (DSM-5: 299.00) by Autism Diagnostic Interview (ADI-R), Social Communication Questionnaire (SCQ), and Autism Diagnostic Observation SChedule-2 (ADOS-2); substantial gastrointestinal symptoms (as indicated by score of greater than 7 on the Gastrointestinal Symptoms Severity Index)
- •for autistic children without GI symptoms: confirmed diagnosis of autism spectrum disorder (ASD) and its severity (DSM-5: 299.00) by Autism Diagnostic Interview (ADI-R), Social Communication Questionnaire (SCQ), and Autism Diagnostic Observation SChedule-2 (ADOS-2)
- •for controls: healthy children
排除标准
- •severe sensory impairment
- •brain injury
- •major psychiatric illness (e.g., psychotic disorders that might interfere with assessment). (however, children with common psychological problems such as depression and attention deficit hyperactivity disorder will not be excluded, given that doing so would result in a sample of children with ASD that would be unrepresentative of the pediatric ASD population as a whole.)- children who appear genetically syndromic (based on exam in the pediatric GI clinic)
- •taking immunosuppressive medications
- •abnormal screening labs
- •GI diseases
- •allergy to antibiotics
- •fever or a pre-existing adverse event monitored in the study
- •known history of hepatitis B/C or HIV
- •known pregnancy
- •use of probiotics in the last 60 d
- •use of oral antibiotics/anti-fungal during the previous 2 weeks
- •indwelling catheters/prosthetic devices
结局指标
主要结局
Fecal Mycobiome Composition as assessed by sequencing of fecal fungal species
时间窗: day 1
次要结局
- Oral Mycobiome Composition as assessed by sequencing of oral fungal species(day 1)
- Presence of fungal species Saccharomyces cerevisiae(day 1)
- Antifungal immunity as assessed by serum dectin 1 levels(day 1)
- Presence of fungal species Candida tropicalis(day 1)
- Gastrointentinal (GI) symptoms as assessed by the GI Symptoms Severity Index(day 1)
- Gut inflammation as assessed by fecal calprotectin levels(day 1)
- Presence of fungal species Candida albicans(day 1)
- Behavioral problems as assessed by the Aberrant Behavior Checklist (ABC)(day 1)
- Behavioral problems as assessed by the Social Responsiveness Scale-2 (SRS-2)(day 1)
研究者
Jane J Alookaran
Pediatric gastroenterology fellow
The University of Texas Health Science Center, Houston