Gut Peptides and Intestinal Permeability in Celiac Disease and Irritable Bowel Syndrome

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.

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Key information

Conditions

Celiac Disease Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute of Digestive Diseases IRCCS "S. de Bellis"

Castellana Grotte, Bari, 70013, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Plasma concentrations of GI peptides (Zonulin, GLP-2, Ghrelin and EGF)

Time frame: within one month after the enrollment

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Other

Registry information

Official study title

Gut Peptides and Intestinal Permeability in Celiac Patients, Healthy Subjects and IBS Patients: a Comparative Study

Acronym: PPCD

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Apr 10, 2012
Registry last updated: Nov 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed