Intestinal Inflammation and Carbohydrate Digestion in Autistic Children
Status unconfirmed · Not applicable
Conditions studied: Autism, Inflammation
In brief
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.
Key facts
- Study ID
- NCT00227487
- Run by
- Massachusetts General Hospital
- People needed
- 115
- Starts
- 2005-10-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2016-09-30
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Newton Wellesley Hospital — Newton, Massachusetts, United States
Full record on ClinicalTrials.gov
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