ClinicalTrials.Veeva

Menu

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

A

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Status

Completed

Conditions

Irritable Bowel Syndrome
Celiac Disease

Study type

Observational

Funder types

Other

Identifiers

NCT01574209
CD5X1000

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

70 participants in 3 patient groups

Celiac Disease
Description:
Patients suffering from coeliac diseases confirmed by small intestinal biopsy
IBS patients
Description:
Patients suffering from irritable bowel syndrome (IBS) according to Rome III criteria
Healthy subjects
Description:
Healthy subjects as control group

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems