Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Intestinal Inflammation and Carbohydrate Digestion in Autistic Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Autism Speaks
Information provided by (Responsible Party):
Rafail Kushak, Ph.D., Massachusetts General Hospital Identifier:
First received: September 26, 2005
Last updated: April 25, 2012
Last verified: April 2012
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.


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Evaluation of Intestinal Inflammation and Carbohydrate Digestion in Children With Autistic Spectrum Disorders

Further study details as provided by Massachusetts General Hospital:

Biospecimen Retention:   Samples Without DNA
stool, urine

Enrollment: 100
Study Start Date: October 2005
Estimated Study Completion Date: December 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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 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.

Ages Eligible for Study:   18 Months to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with and without autism who have documented gastrointestinal symptoms requiring endoscopy and colonoscopy with biopsy for the standard medical treatment of their gastrointestinal symptoms

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00227487

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
Study Chair: Harland S. Winter, MD Massachusets General Hospital
Study Director: Timothy M Buie, M.D. Massachusetts General Hospital
  More Information

Additional Information:
Responsible Party: Rafail Kushak, Ph.D., Assistant in Biochemistry, Massachusetts General Hospital Identifier: NCT00227487     History of Changes
Other Study ID Numbers: KRPP1 
Study First Received: September 26, 2005
Last Updated: April 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Additional relevant MeSH terms:
Pathologic Processes processed this record on September 27, 2016