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

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ClinicalTrials.gov Identifier: NCT01574209
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : November 9, 2012
Sponsor:
Information provided by (Responsible Party):
Giuseppe Riezzo, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Tracking Information
First Submitted Date March 28, 2012
First Posted Date April 10, 2012
Last Update Posted Date November 9, 2012
Study Start Date April 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 5, 2012)
Plasma concentrations of GI peptides (Zonulin, GLP-2, Ghrelin and EGF) [ Time Frame: within one month after the enrollment ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 5, 2012)
Intestinal permeability [ Time Frame: 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gut Peptides and Intestinal Permeability in Celiac Disease and Irritable Bowel Syndrome
Official Title Gut Peptides and Intestinal Permeability in Celiac Patients, Healthy Subjects and IBS Patients: a Comparative Study
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 Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Outpatients recruited in IRCCS "S. de Bellis"
Condition
  • Celiac Disease
  • Irritable Bowel Syndrome
Intervention Not Provided
Study 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 8, 2012)
70
Original Estimated Enrollment
 (submitted: April 5, 2012)
45
Actual Study Completion Date October 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01574209
Other Study ID Numbers CD5X1000
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Giuseppe Riezzo, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Study Sponsor Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Collaborators Not Provided
Investigators
Principal Investigator: Giuseppe Riezzo, MD National Institute of Digestive Diseases IRCCS "S. de Bellis"
PRS Account Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Verification Date November 2012