An observational study in Celiac Disease and Irritable Bowel Syndrome, sponsored by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis. Completed at 1 site in Italy. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-11-09.
Sponsored by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · Observational
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 70 is below the median of 150 across 178 observational studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis is the lead sponsor of 54 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Outpatients recruited in IRCCS "S. de Bellis"
Inclusion criteria of celiac disease patients:
Inclusion criteria of IBS patients.
Exclusion criteria for both the above groups:
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
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.
Time frame: within one month after the enrollment
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis