Clinical trial NCT03494088: Mycobiome Evaluation in Children With Autism & GI Symptoms
Official title: Mycobiome Evaluation in Children With Autism & GI Symptoms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism
Gastrointenstinal Symptoms
Keywords: Autism
Abdominal Pain
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Baylor College of Medicine
First posted: 2018-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects will be recruited from The University of Texas Health Science Center at Houston general pediatrics clinic and adolescent clinic.

Children with autism are referred to The University of Texas Health Science Center at Houston general pediatrics clinic and adolescent clinic.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Fecal Mycobiome Composition as assessed by sequencing of fecal fungal species
timeFrame: day 1
Secondary outcomes:
measure: Presence of fungal species Candida tropicalis
timeFrame: day 1
measure: Presence of fungal species Candida albicans
timeFrame: day 1
measure: Presence of fungal species Saccharomyces cerevisiae
timeFrame: day 1
measure: Gastrointentinal (GI) symptoms as assessed by the GI Symptoms Severity Index
timeFrame: day 1
measure: Behavioral problems as assessed by the Aberrant Behavior Checklist (ABC)
timeFrame: day 1
measure: Behavioral problems as assessed by the Social Responsiveness Scale-2 (SRS-2)
timeFrame: day 1
measure: Oral Mycobiome Composition as assessed by sequencing of oral fungal species
timeFrame: day 1
measure: Gut inflammation as assessed by fecal calprotectin levels
timeFrame: day 1
measure: Antifungal immunity as assessed by serum dectin 1 levels
timeFrame: day 1
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
References: