The purpose of the study was 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
Autism Inflammation

Further study details as provided by Massachusetts General Hospital:

Expected Total Enrollment:  100

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 orally administered substances. 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   -   17 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. Age 18 months to 17 years inclusive.
2. Subjects referred to a Massachusetts General Hospital for Children (MGH Main Campus or satellite clinic) for pediatric gastroenterology care.
3. Subjects with documented gastrointestinal symptoms requiring endoscopy with biopsy for the standard medical treatment of their gastrointestinal symptoms (i.e. endoscopy with biopsy cannot be performed solely for research purposes).

Exclusion Criteria:

1. Use of digestive enzymes up to 7 days prior to endoscopy.

Please refer to this study by ClinicalTrials.gov identifier  NCT00227487

Rafail I. Kushak, PhD., Dr.Sc.      617-726-7451    kushak.rafail@mgh.harvard.edu
Timothy M. Buie, MD      617-724-1748    tbuie@partners.org

Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States

Study chairs or principal investigators

Harland S. Winter, MD,  Study Chair,  Massachusets General Hospital   

Study ID Numbers:  KRPP1
Last Updated:  December 8, 2005
Record first received:  September 26, 2005
ClinicalTrials.gov Identifier:  NCT00227487
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10