Mycobiome Evaluation in Children With Autism & GI Symptoms
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 4 - 16 |
| Updated: | 5/16/2018 |
| Start Date: | March 22, 2018 |
| End Date: | May 1, 2019 |
| Contact: | Jane J Alookaran, MD |
| Email: | Jane.J.Alookaran@uth.tmc.edu |
| Phone: | 713-500-6098 |
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.
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.
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
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
Phone: 713-797-7429
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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