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
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|Condition or disease|
|Celiac Disease Irritable Bowel Syndrome|
|Study Type :||Observational|
|Actual Enrollment :||70 participants|
|Official Title:||Gut Peptides and Intestinal Permeability in Celiac Patients, Healthy Subjects and IBS Patients: a Comparative Study|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||October 2012|
Patients suffering from coeliac diseases confirmed by small intestinal biopsy
Patients suffering from irritable bowel syndrome (IBS) according to Rome III criteria
Healthy subjects as control group
- Plasma concentrations of GI peptides (Zonulin, GLP-2, Ghrelin and EGF) [ Time Frame: within one month after the enrollment ]
- 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.
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574209
|National Institute of Digestive Diseases IRCCS "S. de Bellis"|
|Castellana Grotte, Bari, Italy, 70013|
|Principal Investigator:||Giuseppe Riezzo, MD||National Institute of Digestive Diseases IRCCS "S. de Bellis"|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Giuseppe Riezzo, Director of Experimental Pathophysiology Laboratory, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis|
|Other Study ID Numbers:||
|First Posted:||April 10, 2012 Key Record Dates|
|Last Update Posted:||November 9, 2012|
|Last Verified:||November 2012|
Irritable Bowel Syndrome
Colonic Diseases, Functional
Digestive System Diseases