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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 4 Years and 16 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Children with Autism with gastrointestinal (GI) symtpoms
Children with Autism without gastrointestinal (GI) symtpoms
Healthy Children

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Jane J Alookaran, MD
713-797-7429
Jane.J.Alookaran@uth.tmc.edu

More Details

Status
Unknown status
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Jane J Alookaran, MD
713-500-6098
Jane.J.Alookaran@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.