Intestinal Permeability in Children/Adolescents With Functional Dyspepsia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nancy Neilan, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00363597
First received: August 11, 2006
Last updated: February 28, 2012
Last verified: February 2012
  Purpose

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

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 42
Study Start Date: August 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • abdominal pain of at least 8 weeks duration and fulfilling Rome II symptom based criteria for functional dyspepsia (patient group only);
  • undergoing endoscopy to evaluate FD following demonstration of a lack of clinical response to standard acid reduction therapy (patient group only); and,
  • informed permission/assent

Exclusion Criteria:

  • previous abdominal surgery;
  • any chronic non-gastrointestinal illness requiring regular medical care (e.g. diabetes mellitus, juvenile rheumatoid arthritis, cystic fibrosis, cancer);
  • any history of an adverse reaction to lactulose or mannitol;
  • any use of antacids or laxatives within 1 week prior to the study;
  • any use of steroids, antihistamines or antihistamine-like drugs within 4 weeks prior to the study;
  • any use of aspirin is prohibited within one week prior to the study;
  • any use of non-steroidal anti-inflammatory drugs (NSAIDs) other than aspirin is restricted within one week prior to the study or at the discretion of the Study Physician;
  • any use of antibiotics including neomycin (Mycifradin) within 4 weeks prior to the study;
  • pregnancy;
  • any current or chronic history within the previous 6 months of gastrointestinal symptoms including abdominal pain or discomfort, nausea, vomiting, bloating, diarrhea or constipation (healthy control group only); or
  • non-English speaking
  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 ClinicalTrials.gov identifier: NCT00363597

Locations
United States, Missouri
The Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Nancy A. Neilan, MT (ASCP) The Children's Mercy Hospital and Clinics
  More Information

No publications provided by Children's Mercy Hospital Kansas City

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nancy Neilan, Clinical Trials Coordinator, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00363597     History of Changes
Other Study ID Numbers: 0606-104
Study First Received: August 11, 2006
Last Updated: February 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
dyspepsia
gastrointestinal disease
indigestion

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on September 18, 2014