NCT00363597

Completed

Intestinal Permeability in Children/Adolescents With Functio...

Children's Mercy Hospital Kansas City Source

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Other study identifiers

Sponsor study identifier

0606-104

Study Type

observational

Actual enrollment (reported)

42

Locations

1 country

Sites

1

Timeline

Study Start

August 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2010

Actual (reported)

Study Completion

July 2010

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 42 participants
Study completion date: July 2010
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2006
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
August 11, 2006
Actual (reported)
First Posted
August 15, 2006
Actual (reported)
Primary Completion
July 2010
Actual (reported)
Study Completion
July 2010
Actual (reported)

Last Updated: December 19, 2020
Status Verified: December 2020
Last Update Submitted: December 16, 2020

Conditions

Functional Dyspepsia

Keywords

dyspepsiagastrointestinal diseaseindigestion

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

Age8 Years - 17 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

Sampling MethodNon-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);

Sponsors & Collaborators

Children's Mercy Hospital Kansas City
Otherlead

Study Sites (1)

The Children's Mercy Hospital and Clinics

Kansas City, Missouri, 64108, United States

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: 24886078DERIVED

MeSH Terms

Conditions

DyspepsiaGastrointestinal Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsDigestive System Diseases

Study Officials

Craig A. Friesen, MD
The Children's Mercy Hospital and Clinics
PRINCIPAL INVESTIGATOR

Enrollment

42 participants (actual enrollment reported by the registry).

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 2006

Date type not reported

This date has not been verified as actual or estimated.

NCT00323817

To Evaluate the Efficacy and Safety in Subjects With Functional Dyspepsia

Phase 2Completed

NCT05655819

A Study of Glutamine to Treat Intestinal Permeability in Functional Dyspepsia

Phase 1/2Completed

NCT01052896

Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition

Phase 3Withdrawn

NCT00220883

Electrogastrogram (EGG) Reproducibility Study: EEG Readings in Normal Subjects and Dyspeptic Patients

Completed

SYFbcdfa8909ef84abc865ba24a3ac3214a

Evaluation of the effectiveness and safety of ALKACITRAT® on the treatment of functional dyspepsia

Phase 4Recruiting

NCT05836597

Functional Dyspepsia Treatment Using Virtual Reality

Not ApplicableRecruiting

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

Contact the study team to confirm eligibility.

Primary Completion

July 2010

Actual (reported)

Study Completion

July 2010

Actual (reported)

Last Updated

December 19, 2020

Record last verified: 2020-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00363597
Data provider: ClinicalTrials.gov
Source updated: 2020-12-19
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:12 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations