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This study investigated whether improving digestive (gastrointestinal) symptoms affects autism symptoms and oxidative stress in children with autism spectrum disorder and functional constipation. It included children aged 5-17 with a diagnosis of autism and functional constipation. It was a study with no assigned phase and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria:
* English or Spanish-speaking of any ethnicity
* Boys or girls aged 5 years 0 months to 17 years 11 months
* A clinical diagnosis of functional constipation (FC) for the ASD+/FC+ group, with or without encopresis
* Clinical assessment of ASD using Diagnostic and Statistical Manual of Mental Disorders (DSM IV or V criteria)
* ADOS-validated diagnosis of ASD
* Gestational age between 36 and 42 weeks
* Birth weight of at least 2500 grams
* Children with suspected or an existing clinical diagnosis of ASD and FC will be recruited and consented for the study. Assessments and clinical diagnosis may be completed and confirmed through the Baseline study visit for subjects to be eligible.
* Teacher participation is not required for child participation. However, teacher participation will be requested around the time of child enrollment.
Exclusion Criteria:
* Severe sensory or motor impairments (deafness, blindness;
* Identified inherited metabolic, syndromic, or progressive neurological disorders (including epilepsy, Down Syndrome, Rett Syndrome, Tuberous Sclerosis, Neurofibromatosis, Fragile X Syndrome);
* A non-functional GID, such as ulcerative colitis, Celiac disease or Hirschsprung's disease;
* Failure to meet birth weight/gestational age as noted above
* Participation in another ASD research study at the same time
* Not enrolled in an ASD intervention program