We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Intestinal Permeability in Children/Adolescents With Functional Dyspepsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00363597
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : March 1, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Functional Dyspepsia Device: in vitro and in vivo permeability testing

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Intestinal Permeability and Serum Zonulin Concentration in Children/Adolescents With Functional Dyspepsia
Study Start Date : August 2006
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. differential sugar absorption test, serum zonulin [ Time Frame: 5 hour urine collection after administration of test article, serum collected during study visit ]

Secondary Outcome Measures :
  1. Behavioral Assessment Scale for Children (BASC) anxiety scores [ Time Frame: collected during study visit ]
  2. T-lymphocyte, eosinophil and mast cell densities on duodenal biopsy samples [ Time Frame: collected during biopsy, patient group only ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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): NCT00363597

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
Principal Investigator: Nancy A. Neilan, MT (ASCP) The Children's Mercy Hospital and Clinics
More Information

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
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: March 1, 2012
Last Verified: February 2012

Keywords provided by Nancy Neilan, Children's Mercy Hospital Kansas City:
gastrointestinal disease

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