Intestinal Inflammation and Carbohydrate Digestion in Autistic Children
The Evaluation of Intestinal Inflammation and Carbohydrate Digestion in Children With Autistic Spectrum Disorders
1 other identifier
interventional
115
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2005
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2005
CompletedFirst Posted
Study publicly available on registry
September 28, 2005
CompletedStudy Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedSeptember 30, 2016
September 1, 2016
5.6 years
September 26, 2005
September 28, 2016
Conditions
Keywords
Study Arms (1)
Stool collection, Carbohydrate administration, Questionnaires
OTHERA 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
Interventions
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Autism Speakscollaborator
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Newton Wellesley Hospital
Newton, Massachusetts, 02462, United States
Related Publications (1)
Kushak RI, Buie TM, Murray KF, Newburg DS, Chen C, Nestoridi E, Winter HS. Evaluation of Intestinal Function in Children With Autism and Gastrointestinal Symptoms. J Pediatr Gastroenterol Nutr. 2016 May;62(5):687-91. doi: 10.1097/MPG.0000000000001174.
PMID: 26913756DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Harland S. Winter, MD
Massachusets General Hospital
- STUDY DIRECTOR
Timothy M Buie, M.D.
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant in Biochemistry
Study Record Dates
First Submitted
September 26, 2005
First Posted
September 28, 2005
Study Start
October 1, 2005
Primary Completion
May 1, 2011
Study Completion
December 1, 2017
Last Updated
September 30, 2016
Record last verified: 2016-09