Intestinal Inflammation and Carbohydrate Digestion in Autistic Children - Full Text View

Sponsors and Collaborators:	Massachusetts General Hospital Cure Autism Now Foundation
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00227487

Purpose

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
Autism Inflammation

MedlinePlus related topics: Autism

U.S. FDA Resources

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

Further study details as provided by Massachusetts General Hospital:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

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)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Months to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria

Use of any proteolytic digestive enzyme supplements: prescription or over-the-counter (e.g., Pancrease [Creon-10], Lactase, etc.) up to 7 days prior to EGD with biopsy.
Diagnosed bleeding disorder
Hypoalbuminemia
Unstable respiratory status evidenced by a diagnosed respiratory condition (such as asthma) that is not adequately controlled (e.g. evidence of repeated hospitalizations for exacerbations in asthma symptoms, etc.).
Unstable cardiac status evidenced by a diagnosed cardiac condition.
Nasal or menstrual bleeding. Additional blood in stool may effect calprotectin and lactoferrin concentration.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227487

Locations

United States, Massachusetts
Newton Wellesley Hospital
Newton, Massachusetts, United States, 02462
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Cure Autism Now Foundation

Investigators

Study Chair:	Harland S. Winter, MD	Massachusets General Hospital
Study Director:	Timothy M Buie, M.D.	Massachusetts General Hospital

More Information

Related Info This link exits the ClinicalTrials.gov site

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
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

autism
intestine
disaccharidases
inflammation
permeability

Study placed in the following topic categories:

Developmental Disabilities
Child Development Disorders, Pervasive
Mental Disorders

Autistic Disorder
Mental Disorders Diagnosed in Childhood
Inflammation

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009