Intestinal Inflammation and Carbohydrate Digestion in Autistic Children

Summary

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.

Conditions

• Autism
• Inflammation

Interventions

OTHER

Stool collection

Stool sample will be obtained by parent at home to prevent sample dilution during the cleanout

OTHER

Administration of carbohydrate solution during clinically indicated endoscopy

* A carbohydrate solution (lactulose + rhamnose dissolved in tap water) will be administered during the procedure (upper endoscopy) through a catheter directly into the duodenum to allow for intestinal permeability analysis. * Clinically indicated pinch biopsies will then be obtained. * The endoscopy procedures will take at least 1 - 1 ½ hours. * Children will then typically recover in the endoscopy suite for 2 - 2½ hours or less, if the child is medically cleared to leave the endoscopy suite sooner. * Urine for intestinal permeability analysis will be collected during 5 hours after carbohydrate solution administration. If the child has not voided, an additional 60 minutes will be allowed for the child to void. If the child is not continent for urine, a bag will be applied to catch the specimen.

OTHER

Questionnaires

Parents/legal guardians of subjects will be asked to complete five (5) questionnaires: the Gastrointestinal Symptoms Inventory; a Developmental Screening for Autism - based on the child's age, either the Checklist for Autism in Toddlers (CHAT), Modified Checklist for Autism in Toddlers (M-CHAT), or the Social Communication Questionnaire (SCQ); the Behavior and Sensory Interest Questionnaire (BSI), the Behavior Problems Inventory (BPI), and the Aberrant Behavior Checklist (ABC). It should take parents/guardians no longer than eighty-five (85) minutes to complete all 5 surveys. Results from these questionnaires will be correlated with documented gastrointestinal and/or neurological diagnostic information from subject medical records and with research study test results.

Sponsors & Collaborators

• Autism Speaks

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Harland S. Winter, MD · Massachusets General Hospital

• Timothy M Buie, M.D. · Massachusetts General Hospital

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Months

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-10-31

Primary Completion

2011-05-31

Completion

2017-12-31

Countries

• United States

Study Locations