Mycobiome Evaluation in Children With Autism & GI Symptoms

Autism Clinical Trial

Official title:

Mycobiome Evaluation in Children With Autism & GI Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03494088
• Other study ID #: HSC-MS-17-1015
• Status: Recruiting
• Start date: March 22, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: May 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: Jane J Alookaran, MD
• Phone: 713-500-6098
• Email: Jane.J.Alookaran[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autistic Disorder
• Gastrointenstinal Symptoms

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal Mycobiome Composition as assessed by sequencing of fecal fungal species		day 1
Secondary	Presence of fungal species Candida tropicalis		day 1
Secondary	Presence of fungal species Candida albicans		day 1
Secondary	Presence of fungal species Saccharomyces cerevisiae		day 1
Secondary	Gastrointentinal (GI) symptoms as assessed by the GI Symptoms Severity Index		day 1
Secondary	Behavioral problems as assessed by the Aberrant Behavior Checklist (ABC)		day 1
Secondary	Behavioral problems as assessed by the Social Responsiveness Scale-2 (SRS-2)		day 1
Secondary	Oral Mycobiome Composition as assessed by sequencing of oral fungal species		day 1
Secondary	Gut inflammation as assessed by fecal calprotectin levels		day 1
Secondary	Antifungal immunity as assessed by serum dectin 1 levels		day 1