Gut Peptides and Intestinal Permeability in Celiac Disease and Irritable Bowel Syndrome (PPCD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giuseppe Riezzo, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
ClinicalTrials.gov Identifier:
NCT01574209
First received: March 28, 2012
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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.


Condition
Celiac Disease
Irritable Bowel Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Gut Peptides and Intestinal Permeability in Celiac Patients, Healthy Subjects and IBS Patients: a Comparative Study

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis:

Primary Outcome Measures:
  • Plasma concentrations of GI peptides (Zonulin, GLP-2, Ghrelin and EGF) [ Time Frame: within one month after the enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intestinal permeability [ Time Frame: within one month after the enrollment ] [ Designated as safety issue: No ]
    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.


Enrollment: 70
Study Start Date: April 2012
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Celiac Disease
Patients suffering from coeliac diseases confirmed by small intestinal biopsy
IBS patients
Patients suffering from irritable bowel syndrome (IBS) according to Rome III criteria
Healthy subjects
Healthy subjects as control group

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Outpatients recruited in IRCCS "S. de Bellis"

Criteria

Inclusion criteria of celiac disease patients:

  • Diagnosis of CD was based on the detection of IgA antiendomysial and IgA antitissue transglutaminase antibodies in serum
  • Diagnosis must be confirmed by a small intestinal biopsy obtained at the time of gastrointestinal endoscopy.
  • All patients must show Marsh 3 grade villous atrophy at the time of the diagnosis.

Inclusion criteria of IBS patients.

  • Subjects suffering from irritable bowel syndrome according to the Rome III criteria.
  • Availability of at least one GI imaging study during the last five years (colonoscopy, sigmoidoscopy, abdominal ultrasound, barium enema)

Exclusion criteria for both the above groups:

  • None were taking anti-inflammatory drugs (including mast cell stabilisers, histamine antagonists, anticholinergics, anti-diarrhoea medication, probiotics, immunosuppressants and steroids)
  • Presence of organic syndrome, including food allergy, atopy and severe clinical depression or anxiety.
  • Abnormal laboratory data or thyroid function
  • Major abdominal surgery Healthy subjects will be recruited in the administrative staff of the Institute after thorough exclusion of GI symptoms.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01574209

Locations
Italy
National Institute of Digestive Diseases IRCCS "S. de Bellis"
Castellana Grotte, Bari, Italy, 70013
Sponsors and Collaborators
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Investigators
Principal Investigator: Giuseppe Riezzo, MD National Institute of Digestive Diseases IRCCS "S. de Bellis"
  More Information

Publications:
Responsible Party: Giuseppe Riezzo, Director of Experimental Pathophysiology Laboratory, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
ClinicalTrials.gov Identifier: NCT01574209     History of Changes
Other Study ID Numbers: CD5X1000
Study First Received: March 28, 2012
Last Updated: November 8, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis:
Celiac disease
IBS
Intestinal barrier
Intestinal permeability
GI peptides

Additional relevant MeSH terms:
Celiac Disease
Irritable Bowel Syndrome
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Colonic Diseases, Functional
Colonic Diseases

ClinicalTrials.gov processed this record on August 28, 2014