Intestinal Permeability in Children/Adolescents With Functional Dyspepsia
The main purpose of this study is to evaluate whether intestinal permeability and/or serum zonulin concentration is increased in children/adolescents with functional dyspepsia (FD). The study will also explore the relationships between intestinal permeability, mucosal inflammation and anxiety in FD patients.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Intestinal Permeability and Serum Zonulin Concentration in Children/Adolescents With Functional Dyspepsia|
- differential sugar absorption test, serum zonulin [ Time Frame: 5 hour urine collection after administration of test article, serum collected during study visit ] [ Designated as safety issue: No ]
- Behavioral Assessment Scale for Children (BASC) anxiety scores [ Time Frame: collected during study visit ] [ Designated as safety issue: No ]
- T-lymphocyte, eosinophil and mast cell densities on duodenal biopsy samples [ Time Frame: collected during biopsy, patient group only ] [ Designated as safety issue: No ]
|Study Start Date:||August 2006|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Device: in vitro and in vivo permeability testing
single oral dose, 2 mL/kg (maximum 100 mL) of Sugar Absorption Solution containing 5 gm lactulose, 2 gm mannitol and 40 gm sucrose dissolved in demineralized water.
Recurrent abdominal pain is a common complaint among school-age children, being present in up to 15% at any given time. It represents the most common chronic pain entity in pediatric patients. The great majority of these patients will have a functional gastrointestinal disorder (FGID). The most common FGID in these patients is functional dyspepsia (FD), defined as upper abdominal pain or discomfort unrelieved by bowel movement and in the absence of a structural or biochemical explanation for the pain. The etiology of FD is multifactorial, including biological factors, and these factors can be viewed within a biopsychosocial model. Biological factors include inflammation, dysmotility and increased visceral sensitivity. These biological factors are influenced by and are interactive with psychosocial factors such as anxiety, depression and social interaction. This study will evaluate intestinal permeability as a measure of barrier dysfunction and investigate the correlations between increased permeability, mucosal inflammation and anxiety scores to provide further insight into the etiology of FD, thereby assisting in the development and selection of treatment modalities.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00363597
|United States, Missouri|
|The Children's Mercy Hospital and Clinics|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Nancy A. Neilan, MT (ASCP)||The Children's Mercy Hospital and Clinics|