Intestinal Permeability in Children/Adolescents With Functional Dyspepsia

Functional Dyspepsia Clinical Trial

Official title:

Intestinal Permeability and Serum Zonulin Concentration in Children/Adolescents With Functional Dyspepsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00363597
• Other study ID #: 0606-104
• Status: Completed
• Start date: August 2006
• Est. completion date: July 2010

Study information

• Verified date: December 2020
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Locations

Country	Name	City	State
United States	The Children's Mercy Hospital and Clinics	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	differential sugar absorption test, serum zonulin		5 hour urine collection after administration of test article, serum collected during study visit
Secondary	Behavioral Assessment Scale for Children (BASC) anxiety scores		collected during study visit
Secondary	T-lymphocyte, eosinophil and mast cell densities on duodenal biopsy samples		collected during biopsy, patient group only