Clinical trial NCT01574209: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease
Irritable Bowel Syndrome
Keywords: Celiac disease
IBS
Intestinal barrier
Intestinal permeability
GI peptides
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients recruited in IRCCS "S. 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.


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.

Primary outcomes:
measure: Plasma concentrations of GI peptides (Zonulin, GLP-2, Ghrelin and EGF)
timeFrame: within one month after the enrollment
Secondary outcomes:
measure: Intestinal permeability
timeFrame: within one month after the enrollment
Other outcomes:
Locations:
city: Castellana Grotte
country: Italy
facility: National Institute of Digestive Diseases IRCCS "S. de Bellis"
state: Bari
Study officials:
affiliation: National Institute of Digestive Diseases IRCCS "S. de Bellis"
name: Giuseppe Riezzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Linsalata M, Riezzo G, D'Attoma B, Clemente C, Orlando A, Russo F. Noninvasive biomarkers of gut barrier function identify two subtypes of patients suffering from diarrhoea predominant-IBS: a case-control study. BMC Gastroenterol. 2018 Nov 6;18(1):167. doi: 10.1186/s12876-018-0888-6.
citation: Russo F, Chimienti G, Clemente C, D'Attoma B, Linsalata M, Orlando A, De Carne M, Cariola F, Semeraro FP, Pepe G, Riezzo G. Adipokine profile in celiac patients: differences in comparison with patients suffering from diarrhea-predominant IBS and healthy subjects. Scand J Gastroenterol. 2013 Dec;48(12):1377-85. doi: 10.3109/00365521.2013.845907. Epub 2013 Oct 28.