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Mycobiome Evaluation in Children With Autism & GI Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494088
Recruitment Status : Unknown
Verified May 2018 by Jane J Alookaran, The University of Texas Health Science Center, Houston.
Recruitment status was:  Recruiting
First Posted : April 11, 2018
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
Jane J Alookaran, The University of Texas Health Science Center, Houston

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.

Condition or disease
Autism Gastrointenstinal Symptoms

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mycobiome Evaluation in Children With Autism & GI Symptoms
Actual Study Start Date : March 22, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019

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



Primary Outcome Measures :
  1. Fecal Mycobiome Composition as assessed by sequencing of fecal fungal species [ Time Frame: day 1 ]

Secondary Outcome Measures :
  1. Presence of fungal species Candida tropicalis [ Time Frame: day 1 ]
  2. Presence of fungal species Candida albicans [ Time Frame: day 1 ]
  3. Presence of fungal species Saccharomyces cerevisiae [ Time Frame: day 1 ]
  4. Gastrointentinal (GI) symptoms as assessed by the GI Symptoms Severity Index [ Time Frame: day 1 ]
  5. Behavioral problems as assessed by the Aberrant Behavior Checklist (ABC) [ Time Frame: day 1 ]
  6. Behavioral problems as assessed by the Social Responsiveness Scale-2 (SRS-2) [ Time Frame: day 1 ]
  7. Oral Mycobiome Composition as assessed by sequencing of oral fungal species [ Time Frame: day 1 ]
  8. Gut inflammation as assessed by fecal calprotectin levels [ Time Frame: day 1 ]
  9. Antifungal immunity as assessed by serum dectin 1 levels [ Time Frame: day 1 ]

Biospecimen Retention:   Samples Without DNA
  • Blood
  • Saliva
  • Stool


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494088


Contacts
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Contact: Jane J Alookaran, MD 713-500-6098 Jane.J.Alookaran@uth.tmc.edu
Contact: Nicole Fatheree (713) 500-5669 Nicole.Fatheree@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Jane J Alookaran, MD    713-797-7429    Jane.J.Alookaran@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Baylor College of Medicine
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Responsible Party: Jane J Alookaran, Pediatric gastroenterology fellow, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03494088    
Other Study ID Numbers: HSC-MS-17-1015
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jane J Alookaran, The University of Texas Health Science Center, Houston:
Autism
Abdominal Pain
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders