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Intestinal Inflammation and Carbohydrate Digestion in Autistic Children

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ClinicalTrials.gov Identifier: NCT00227487
Recruitment Status : Unknown
Verified September 2016 by Rafail Kushak, Ph.D., Massachusetts General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 28, 2005
Last Update Posted : September 30, 2016
Autism Speaks
Information provided by (Responsible Party):
Rafail Kushak, Ph.D., Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Autism Inflammation Other: Stool collection Other: Administration of carbohydrate solution during clinically indicated endoscopy Other: Questionnaires Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Evaluation of Intestinal Inflammation and Carbohydrate Digestion in Children With Autistic Spectrum Disorders
Study Start Date : October 2005
Actual Primary Completion Date : May 2011
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Stool collection, Carbohydrate administration, Questionnaires

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
Stool sample will be obtained by parent at home to prevent sample dilution during the cleanout

Other: Administration of carbohydrate solution during clinically indicated endoscopy
  • 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.

Other: Questionnaires
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.

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Ages Eligible for Study:   18 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227487

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Newton Wellesley Hospital
Newton, Massachusetts, United States, 02462
Sponsors and Collaborators
Massachusetts General Hospital
Autism Speaks
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Study Chair: Harland S. Winter, MD Massachusets General Hospital
Study Director: Timothy M Buie, M.D. Massachusetts General Hospital
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rafail Kushak, Ph.D., Assistant in Biochemistry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00227487    
Other Study ID Numbers: KRPP1
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Keywords provided by Rafail Kushak, Ph.D., Massachusetts General Hospital:
Additional relevant MeSH terms:
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Pathologic Processes