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Sponsors and Collaborators: |
Massachusetts General Hospital Cure Autism Now Foundation |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00227487 |
The purpose of the study is to find correlations between non-invasive fecal tests of intestinal inflammation and macro- and microscopic evaluation of duodenal and colonic histology, disaccharidase activity, and intestinal permeability in children with autism.
Condition |
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Autism Inflammation |
Study Type: | Observational |
Study Design: | Case Control, Cross-Sectional |
Official Title: | The Evaluation of Intestinal Inflammation and Carbohydrate Digestion in Children With Autistic Spectrum Disorders |
stool, urine
Estimated Enrollment: | 100 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Gastrointestinal disorders in children with autism receive little attention. However, symptoms such as abdominal pain, diarrhea, constipation, and flatulence have been considered contributing to the behavioral problems. These symptoms are associated partially with the deficiency of enzymes digesting carbohydrates and inflammation of the gastrointestinal tract. The effect of intestinal inflammation on neurological disorders experienced by autistic children remains unclear. We will study this problem using recently developed non-invasive tests based on two proteins (calprotectin and lactoferrin) analysis in children's stool Activity of enzymes needed for carbohydrate digestion will be tested in small samples of intestinal tissue.
Intestinal permeability will be assessed by measuring urinary excretion of carbohydrate substances administered via the endoscope. This test will help to determine if intestinal inflammation contributes to a "leaky" gut syndrome. The study will provide valuable information for understanding the association between gastrointestinal disease and behavioral problems in autistic children.
Ages Eligible for Study: | 18 Months to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Subjects with and without autism who have documented gastrointestinal symptoms requiring endoscopy and colonoscopy with biopsy for the standard medical treatment of their gastrointestinal symptoms
Inclusion Criteria:
Exclusion Criteria
United States, Massachusetts | |
Newton Wellesley Hospital | |
Newton, Massachusetts, United States, 02462 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Study Chair: | Harland S. Winter, MD | Massachusets General Hospital |
Study Director: | Timothy M Buie, M.D. | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Rafail Kushak, Ph.D., Dr.Sci. ) |
Study ID Numbers: | KRPP1 |
Study First Received: | September 26, 2005 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00227487 History of Changes |
Health Authority: | United States: Institutional Review Board |
autism intestine disaccharidases inflammation permeability |
Child Development Disorders, Pervasive Developmental Disabilities Mental Disorders Autistic Disorder |
Mental Disorders Diagnosed in Childhood Autism Inflammation |
Child Development Disorders, Pervasive Pathologic Processes Mental Disorders |
Autistic Disorder Mental Disorders Diagnosed in Childhood Inflammation |