An interventional study of Stool collection and Administration of carbohydrate solution during clinically indicated endoscopy in Autism and Inflammation, sponsored by Massachusetts General Hospital. Status unknown at 2 sites in United States. Open to participants aged 18 Months to 17 Years. Per ClinicalTrials.gov, last updated 2016-09-30.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Diagnostic
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.
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 (lactulose and rhamnose) 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.
1,360 studies on the registry are indexed under Autistic Disorder; 332 are open to participants now.
This study's enrollment of 115 is above the median of 46 across 1,058 interventional studies indexed under Autistic Disorder.
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Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Exclusion Criteria
A stool sample will be obtained A carbohydrate solution (lactulose plus rhamnose dissolved in tap water) will be administered during a clinically indicated endoscopic procedure. Five questionnaires will be completed by parent/guardian
Other: Stool collection · Other: Administration of carbohydrate solution during clinically indicated endoscopy · Other: Questionnaires
Stool sample will be obtained by parent at home to prevent sample dilution during the cleanout
* 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.
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.
The record gives a start of Oct 2005, a primary completion of May 2011 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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