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Sponsored by: |
Children's Mercy Hospital Kansas City |
Information provided by: | Children's Mercy Hospital Kansas City |
ClinicalTrials.gov Identifier: | NCT00363597 |
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.
Condition | Intervention |
Functional Dyspepsia |
Device: in vitro and in vivo permeability testing |
MedlinePlus related topics: | Anxiety Indigestion |
ChemIDplus related topics: | Mannitol Sucrose Lactulose |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Intestinal Permeability and Serum Zonulin Concentration in Children/Adolescents With Functional Dyspepsia |
Estimated Enrollment: | 60 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental |
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.
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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.
Ages Eligible for Study: | 8 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nancy A. Neilan, MT (ASCP) | 816/983-6398 | naneilan@cmh.edu |
United States, Missouri | |||||
The Children's Mercy Hospital and Clinics | Recruiting | ||||
Kansas City, Missouri, United States, 64108 | |||||
Sub-Investigator: Craig A. Friesen, MD | |||||
Sub-Investigator: Jennifer Schurman, PhD | |||||
Sub-Investigator: Uttam C. Garg, PhD | |||||
Sub-Investigator: Debra Taylor, RN |
Children's Mercy Hospital Kansas City |
Principal Investigator: | Nancy A. Neilan, MT (ASCP) | The Children's Mercy Hospital and Clinics |
Responsible Party: | Children's Mercy Hospitals and Clinics ( Nancy Neilan, MT (ASCP)/ Research Coordinator ) |
Study ID Numbers: | 0606-104 |
First Received: | August 11, 2006 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00363597 |
Health Authority: | United States: Institutional Review Board |
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