Intestinal Permeability in Children/Adolescents With Functional Dyspepsia

NCT00363597 | Completed

• 1 other identifier: 0606-104
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Dyspepsia

Keywords

dyspepsia; gastrointestinal disease; indigestion

Outcome Measures

Primary Outcomes (1)

• differential sugar absorption test, serum zonulin

  5 hour urine collection after administration of test article, serum collected during study visit

Secondary Outcomes (2)

• Behavioral Assessment Scale for Children (BASC) anxiety scores

  collected during study visit

• T-lymphocyte, eosinophil and mast cell densities on duodenal biopsy samples

  collected during biopsy, patient group only

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with chronic abdominal pain.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

The Children's Mercy Hospital and Clinics

Kansas City, Missouri, 64108, United States

Location

Related Publications (1)

• Neilan NA, Garg UC, Schurman JV, Friesen CA. Intestinal permeability in children/adolescents with functional dyspepsia. BMC Res Notes. 2014 May 1;7:275. doi: 10.1186/1756-0500-7-275.

  PMID: 24886078 DERIVED

MeSH Terms

Conditions

Dyspepsia; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Diseases

Study Officials

• Craig A. Friesen, MD

  The Children's Mercy Hospital and Clinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2006
• First Posted: August 15, 2006
• Study Start: August 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 19, 2020

Record last verified: 2020-12

Locations

US (1)