Clinical Research

Genomic, proteomic, biochemical, and immunologic profiling in children with developmental disorder: a comparison with neurotypical children (on-going)

In this 5-year research study, we aim to identify biomedical markers that correlate with behavioral and developmental phenotypes in order to:

• screen populations of children with childhood developmental disorders for underlying inflammatory bowel disease
• identify those children who might benefit from specific treatments
• develop biomarker profiles that form an instrument for monitoring the clinical course of the disease and the therapeutic response to medical intervention
• improve the clinical well-being of affected children and increase our knowledge base of this disease

This prospective study is enrolling male and female children with a childhood developmental disorder, as well as neurotypical controls. To find out if your child meets the inclusion criteria for this study, please contact intake@thoughtfulhouse.org.

Elemental Diet in the Treatment of Children Diagnosed with Autism Presenting with Gastrointestinal Abnormalities (on-going)

The purpose of this investigation is to evaluate the tolerability and efficacy of an Elemental Diet in the amelioration of gastrointestinal symptoms in children with GI dysfunctions and a diagnosis of ASD. The aims of this study are to:

• conduct a prospective open trial of an elemental diet in a population of children with ASD.
• administer a nutritionally adequate elemental diet to children with documented evidence of ileitis, colitis, and/or duodenitis, and lymphoid nodular hyperplasia, with ASD
• quantify symptomatic changes in GI presentation
• quantify anthropometric and biochemical changes

This prospective treatment study is enrolling up to 50 male and female children aged 2-21 years, diagnosed with ASD with documented evidence of ileitis, colitis, and/or duodenitis, and lymphoid nodular hyperplasia. To find out if your child meets the inclusion criteria for this study, please contact intake@thoughtfulhouse.org.

Bone Mineral Density in Boys Diagnosed with Autism Spectrum Disorder (on-going)

The purpose of this investigation is to assess bone mineral density status for boys diagnosed with autism spectrum disorder (ASD). In this study we will examine whether:

• mineral bone density in children with ASD is correlated with nutritional status
• vitamin and mineral levels are correlated with bone mineral density
• bone mineral density is correlated with symptomatic GI presentation
• bone mineral density is correlated with anthropometric measurements

This prospective study is enrolling up to 80 male children aged 4-8 years, diagnosed with ASD. To find out if your child meets the inclusion criteria for this study, please contact intake@thoughtfulhouse.org.

A Retrospective Analysis of Dietary and Nutrient Status of Children with Autism in an Outpatient Setting (on-going)

The main objective of this retrospective study is to compare the intake of calories, carbohydrates, protein, fat, vitamins, and minerals from food in children with autism at baseline and follow-up dietary consultations and assessments. The prevalence of dietary inadequacy of these nutrients in this patient population diagnosed with failure to thrive (FTT) will also be evaluated.

This retrospective analysis will consist of chart review of approximately 600 children with autism who were seen on an outpatient basis at the Nutrition Clinic at Thoughtful House Center for Children in 2009. Children ages 2 years to 21 years with an existing diagnosis of ASD will be included in this study. To find out if your child meets the inclusion criteria for this study, please contact intake@thoughtfulhouse.org.

Effects of Hyperbaric Oxygen Therapy (HBOT) on behavioral measures of short-term memory, learning and behavior in children with autism (completed)

The purpose of this study was to evaluate the cognitive and behavioral effects of Hyperbaric Oxygen Therapy (HBOT) in children who present with a diagnosis of autism spectrum disorder (ASD). This study was designed to:

• provide further evidence for the safety of HBOT in children with ASD
• qualitatively assess the effects of HBOT on behavioral and cognitive symptoms of ASD before, during, and after treatment
• identify the number of treatments required to reach therapeutic effects
• identify the length and durability of treatment effects and maintenance

This study has now been completed and the results published.

Basic Science Research

A primate model of gut, immune, and central nervous system interaction in response to childhood vaccines.

In 2002, Thoughtful House Center for Children embarked on a 5-year collaborative study with researchers at the University of Pittsburgh to develop a primate model for assessing the role of childhood vaccinations in regressive autism. Led by Dr. Laura Hewitson, this non-human primate model for studying vaccine safety enabled us to fully explore the neurodevelopmental, gastrointestinal, and immunologic effects of combined infant vaccine regimens in the most appropriate animal model, the rhesus macaque. Previous vaccine safety studies have tended to examine individual vaccines; none have looked at the potential for synergy and interaction in the context of adverse events. This research model is uniquely capable of providing insights into disease mechanism and cause, as well as having utility in translational studies concerning treatment and prevention.

Based on the success of the pilot study, Phase II of the study is already underway in collaboration with researchers at the University of Washington, Seattle. Phase II is investigating more closely which vaccine(s), or vaccine combinations, result in behavioral and gastrointestinal impairments in infant male rhesus macaques to try to identify any synergistic effects. The study is expected to be completed in 2012.

For more information please see our published papers.

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Dr. Bryan Jepson | Kelly Barnhill, MBA, CN, CNN