Status:
UNKNOWN
Intestinal Inflammation and Carbohydrate Digestion in Autistic Children
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Autism Speaks
Conditions:
Autism
Inflammation
Eligibility:
All Genders
18-17 years
Phase:
NA
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 act...
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 b...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00227487
Start Date
October 1 2005
End Date
December 1 2017
Last Update
September 30 2016
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Newton Wellesley Hospital
Newton, Massachusetts, United States, 02462