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

NCT ID: NCT01574209

Last Updated: 2012-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Celiac Disease Irritable Bowel Syndrome

Keywords

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Celiac disease IBS Intestinal barrier Intestinal permeability GI peptides

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Celiac Disease

Patients suffering from coeliac diseases confirmed by small intestinal biopsy

No interventions assigned to this group

IBS patients

Patients suffering from irritable bowel syndrome (IBS) according to Rome III criteria

No interventions assigned to this group

Healthy subjects

Healthy subjects as control group

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.


* 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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Riezzo

Director of Experimental Pathophysiology Laboratory

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giuseppe Riezzo, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Castellana Grotte, Bari, Italy

Site Status

Countries

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Italy

References

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Fasano A. Zonulin and its regulation of intestinal barrier function: the biological door to inflammation, autoimmunity, and cancer. Physiol Rev. 2011 Jan;91(1):151-75. doi: 10.1152/physrev.00003.2008.

Reference Type BACKGROUND
PMID: 21248165 (View on PubMed)

Cani PD, Possemiers S, Van de Wiele T, Guiot Y, Everard A, Rottier O, Geurts L, Naslain D, Neyrinck A, Lambert DM, Muccioli GG, Delzenne NM. Changes in gut microbiota control inflammation in obese mice through a mechanism involving GLP-2-driven improvement of gut permeability. Gut. 2009 Aug;58(8):1091-103. doi: 10.1136/gut.2008.165886. Epub 2009 Feb 24.

Reference Type BACKGROUND
PMID: 19240062 (View on PubMed)

Gecse K, Roka R, Sera T, Rosztoczy A, Annahazi A, Izbeki F, Nagy F, Molnar T, Szepes Z, Pavics L, Bueno L, Wittmann T. Leaky gut in patients with diarrhea-predominant irritable bowel syndrome and inactive ulcerative colitis. Digestion. 2012;85(1):40-6. doi: 10.1159/000333083. Epub 2011 Dec 14.

Reference Type BACKGROUND
PMID: 22179430 (View on PubMed)

Menard S, Lebreton C, Schumann M, Matysiak-Budnik T, Dugave C, Bouhnik Y, Malamut G, Cellier C, Allez M, Crenn P, Schulzke JD, Cerf-Bensussan N, Heyman M. Paracellular versus transcellular intestinal permeability to gliadin peptides in active celiac disease. Am J Pathol. 2012 Feb;180(2):608-15. doi: 10.1016/j.ajpath.2011.10.019. Epub 2011 Nov 24.

Reference Type BACKGROUND
PMID: 22119716 (View on PubMed)

Malandrino N, Capristo E, Farnetti S, Leggio L, Abenavoli L, Addolorato G, Gasbarrini G. Metabolic and nutritional features in adult celiac patients. Dig Dis. 2008;26(2):128-33. doi: 10.1159/000116770. Epub 2008 Apr 21.

Reference Type BACKGROUND
PMID: 18431062 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30400824 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24164320 (View on PubMed)

Other Identifiers

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CD5X1000

Identifier Type: -

Identifier Source: org_study_id