Gut Peptides and Intestinal Permeability in Celiac Disease and Irritable Bowel Syndrome

Completed

• Conditions: Celiac Disease; Irritable Bowel Syndrome

• Registration Number: NCT01574209
• Lead Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Brief Summary

It is well known that the intestinal barrier is altered in celiac disease (CD), an autoimmune disease that develops in genetically predisposed subjects exposed to ingestion of wheat gliadin and of related prolamines of barley and rye. More recently, defective epithelial barrier has been implicated in the pathogenesis of other conditions such as irritable bowel syndrome (IBS). At present IBS is still considered a functional condition although low-grade inflammation has been associated with its manifestation, particularly that following infection. Different substances have been implicated in the (dis)regulation of intestinal barrier, among them zonulin seems to play a key role. Other gastrointestinal peptides are GPL-2, Ghrelin, and Epidermal growth factor (EGF). In order to shed light on the hormonal regulation of intestinal barrier function in celiac patients before undergoing a gluten free diet and possible differences with those of IBS patients, in the present study the investigators will apply the non-invasive lactulose/mannitol permeability test toward the evaluation of intestinal damage. The pattern of intestinal permeability and the GI peptides concentration will be compared in celiac patients, IBS patients and healthy controls.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-28
• Study Start: 2012-04
• Study First Submitted QC: 2012-04-05
• Study First Posted: 2012-04-10
• Primary Completion: 2012-09
• Study Completion: 2012-10
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-08
• Last Update Posted: 2012-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of GI peptides (Zonulin, GLP-2, Ghrelin and EGF)	within one month after the enrollment

Secondary Outcome Measures

Name	Time	Method
Intestinal permeability	within one month after the enrollment	The detection and measurement of two sugar probes, lactulose (La) and mannitol (Ma), in the urine will be performed by chromatographic analysis. For each sample the percentage of ingested La and Ma in urine will be evaluated and their ratio (La-Ma) will be calculated.

Trial Locations

Locations (1)

National Institute of Digestive Diseases IRCCS "S. de Bellis"; 🇮🇹 Castellana Grotte, Bari, Italy