Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227487
Status:
UNKNOWN
Last Update Posted:
2016-09-30
First Post:
2005-09-26
Brief Title:
Intestinal Inflammation and Carbohydrate Digestion in Autistic Children
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
The Evaluation of Intestinal Inflammation and Carbohydrate Digestion in Children With Autistic Spectrum Disorders
Status:
UNKNOWN
Status Verified Date:
2016-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 childrens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None