Mycobiome Evaluation in Children With Autism & GI Symptoms

Study Overview
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Brief Summary
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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.

Official Title
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Mycobiome Evaluation in Children With Autism & GI Symptoms

Conditions
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Autism, Gastrointenstinal Symptoms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with Autism with gastrointestinal (GI) symtpoms<br> | |
| Children with Autism without gastrointestinal (GI) symtpoms<br> | |
| Healthy Children<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal Mycobiome Composition as assessed by sequencing of fecal fungal species |  | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of fungal species Candida tropicalis |  | day 1 | 
| Presence of fungal species Candida albicans |  | day 1 | 
| Presence of fungal species Saccharomyces cerevisiae |  | day 1 | 
| Gastrointentinal (GI) symptoms as assessed by the GI Symptoms Severity Index |  | 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 | 
| Oral Mycobiome Composition as assessed by sequencing of oral fungal species |  | day 1 | 
| Gut inflammation as assessed by fecal calprotectin levels |  | day 1 | 
| Antifungal immunity as assessed by serum dectin 1 levels |  | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism, Abdominal Pain