Mycobiome Evaluation in Children With Autism & GI Symptoms

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.

Study Overview

• Status: Unknown
• Conditions: Autism; Gastrointenstinal Symptoms

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Jane J Alookaran, MD; Phone Number: 713-500-6098; Email: Jane.J.Alookaran@uth.tmc.edu
• Study Contact Backup: Name: Nicole Fatheree; Phone Number: (713) 500-5669; Email: Nicole.Fatheree@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Jane J Alookaran, MD; Phone Number: 713-797-7429; Email: Jane.J.Alookaran@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Children with Autism with gastrointestinal (GI) symtpoms
Children with Autism without gastrointestinal (GI) symtpoms
Healthy Children

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2018
• Last Update Submitted That Met QC Criteria: May 7, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Abdominal Pain; Autism
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: HSC-MS-17-1015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No