Celiac DiseasePPCDNCT01574209
Gut Peptides and Intestinal Permeability in Celiac Disease and Irritable Bowel Syndrome
An observational study of Celiac Disease and Irritable Bowel Syndrome, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease, Irritable Bowel Syndrome
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2012to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatients recruited in IRCCS "S. de Bellis"
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
National Institute of Digestive Diseases IRCCS "S. de Bellis"
Castellana Grotte, Bari, 70013
About this study
Official title: Gut Peptides and Intestinal Permeability in Celiac Patients, Healthy Subjects and IBS Patients: a Comparative Study
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.
- Conditions
- Celiac Disease, Irritable Bowel Syndrome
- Keywords
- Celiac disease, IBS, Intestinal barrier, Intestinal permeability, GI peptides
- Medical subject headings
- Celiac Disease, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Celiac Disease | Patients suffering from coeliac diseases confirmed by small intestinal biopsy | |
| IBS patients | Patients suffering from irritable bowel syndrome (IBS) according to Rome III criteria | |
| Healthy subjects | Healthy subjects as control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of GI peptides (Zonulin, GLP-2, Ghrelin and EGF)
Measured: within one month after the enrollment
Secondary outcomes (1)
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.
Measured: within one month after the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Riezzo, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Investigators
- Giuseppe Riezzo, MD, Principal investigator, National Institute of Digestive Diseases IRCCS "S. de Bellis"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574209
- Sponsor's protocol ID
- CD5X1000
- Acronym
- PPCD
- Status last verified
- Nov 2012
- First submitted
- 28 Mar 2012
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21248165Cani 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.
PubMed 19240062Gecse 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.
PubMed 22179430Menard 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.
PubMed 22119716Malandrino 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.
PubMed 18431062Linsalata 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.
PubMed 30400824Russo 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.
PubMed 24164320
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Peptides and Intestinal Permeability in Celiac Patients, Healthy Subjects and IBS Patients: a Comparative Study
- ClinicalTrials.gov ID
- NCT01574209
- Acronym / sponsor ID
- PPCD / CD5X1000
- Conditions
- Celiac Disease, Irritable Bowel Syndrome
- Keywords
- Celiac disease, IBS, Intestinal barrier, Intestinal permeability, GI peptides
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Celiac Disease | – | –Patients suffering from coeliac diseases confirmed by small intestinal biopsy |
| IBS patients | – | –Patients suffering from irritable bowel syndrome (IBS) according to Rome III criteria |
| Healthy subjects | – | –Healthy subjects as control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients recruited in IRCCS "S. de Bellis"
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma concentrations of GI peptides (Zonulin, GLP-2, Ghrelin and EGF)
Time frame: within one month after the enrollment
1 secondary outcome
Intestinal permeability
Time frame: within one month after the enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2012.
- Background: PubMed 21248165Fasano 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.
- Background: PubMed 19240062Cani 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.
- Background: PubMed 22179430Gecse 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.
- Background: PubMed 22119716Menard 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.
- Background: PubMed 18431062Malandrino 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.
- Derived from this study: PubMed 30400824Linsalata 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.
- Derived from this study: PubMed 24164320Russo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Riezzo, MD principal investigator
National Institute of Digestive Diseases IRCCS "S. de Bellis"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease and Irritable Bowel Syndrome, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations of GI peptides (Zonulin, GLP-2, Ghrelin and EGF) (time frame: within one month after the enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01574209, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2012.