Status:
UNKNOWN
Study of Fluconazole in Children With Autism Spectrum Disorder
Lead Sponsor:
The Center for Autism and Related Disorders
Collaborating Sponsors:
The International Child Development Resource Center
Thoughtful House
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
3-10 years
Phase:
NA
Brief Summary
Antifungal therapy is widely used for individuals with Autism Spectrum Disorders (ASD). The current investigation will examine the effects of fluconazole on behavioral functioning among children with ...
Eligibility Criteria
Inclusion
- Male or female participants, three to ten years of age.
- Meets clinical criteria for an autism spectrum disorder.
- No antifungal use in the preceding 3 months.
- Results of pyrosequencing analysis that have identified yeast
- Each legal guardian must have a level of understanding sufficient to agree to all required tests and examinations. Each legal guardian must understand the nature of the study and must provide written consent to study protocol.
Exclusion
- History of allergic reaction to fluconazole or other azole antifungal agents
- Current use of terfenadine, cisapride, phenytoin, cyclosporine, rifampin, theophylline, terfenadine, cisapride, astemizole, rifabutin, or tacrolimus
- History of uncontrolled epilepsy
- Weight less than 15 kg at screening
- Presence of a chronic medical condition that might interfere with study participation or where study participation would be contraindicated or clinically significant abnormal baseline laboratory results.
- Recent (less than two months prior to study entry) initiation of behavior therapy
- A child will be excluded at any point during the study if it is revealed that a major change (either addition or deletion) of treatment or service provision has occurred.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00936182
Start Date
July 1 2009
End Date
July 1 2011
Last Update
July 9 2009
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Autism and Related Disorders
Tarzana, California, United States, 91356
2
International Child Development Resource Center
Melbourne, Florida, United States, 32904
3
Thoughtful House
Austin, Texas, United States, 78746