Celiac DiseaseCELIQK2NCT01478867
Detection of Immunotoxic Gluten Peptides in Feces
An observational study of Celiac Disease, run by University of Seville at 1 site in Spain.
Trial summary
The purpose of this study is to monitor of gluten-free diet compliance in celiac patients by assessment of gliadin 33-mer equivalent epitopes in feces. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Detection of gluten in feces
- How many people
- 53 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2011to Jul 2011
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Celiac patients, 1-12 years old
Who may be able to join
- Celiac patient
- 1-12 years old
- Written informed consent
Who cannot join
- Known inflammatory bowel diseases
- Participation in any other studies involving investigational concomitantly or within two weeks prior to entry into the study and during the course of the study
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Microbiology and Parasitology, Faculty of Pharmacy, University of Seville
Seville, Seville, 41012
About this study
Official title: Phase 0 Monitoring of Gluten-free Diet Compliance in Celiac Patients by Assessment of Gliadin 33-mer Equivalent Epitopes in Feces
The purpose of this study is to monitor of gluten-free diet compliance in celiac patients by assessment of gliadin 33-mer equivalent epitopes in feces.
Read the detailed description
Certain immunotoxic peptides from gluten are resistant to gastrointestinal digestion and can interact with celiac patient factors to trigger immunological response. Gluten-free diet (GFD) is the only effective treatment for celiac disease (CD) and its compliance should be monitored to avoid accumulative damage. However, practical methods to monitor diet compliance and to detect the origin of an outbreak of celiac clinical symptoms are not available.
This study assesses the capacity to determine the gluten ingestion, and to monitor the GFD compliance in celiac patients by detection of gluten and gliadin 33-mer equivalent peptidic epitopes in human feces.
- Conditions
- Celiac Disease
- Being tested
- Detection of gluten in feces
- Keywords
- celiac disease, gluten-free diet, gluten peptides, feces
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of gluten in fecesOther
Also called Gluten-free diet, Celiac patients
Detection of Gluten in Feces
| Study group | Role | What they receive |
|---|---|---|
| Celiac patients | Not described Receives: Other: Detection of gluten in feces |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring of gluten-free diet compliance in celiac patients
Usual gluten diet for celiac (home diet not modified for this trial)
Measured: April-July 2011 (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startApr 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Hispalense de Pediatría, Seville, Spain
- Responsible party
- Principal investigator, Carolina Sousa Martin, University of Seville
- Investigators
- Carolina Sousa, Professor, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478867
- Sponsor's protocol ID
- CELIQK2
- Acronym
- CELIQK2
- Status last verified
- Nov 2011
- First submitted
- 21 Nov 2011
- Last updated
- 24 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Moron B, Cebolla A, Manyani H, Alvarez-Maqueda M, Megias M, Thomas Mdel C, Lopez MC, Sousa C. Sensitive detection of cereal fractions that are toxic to celiac disease patients by using monoclonal antibodies to a main immunogenic wheat peptide. Am J Clin Nutr. 2008 Feb;87(2):405-14. doi: 10.1093/ajcn/87.2.405.
PubMed 18258632Moron B, Bethune MT, Comino I, Manyani H, Ferragud M, Lopez MC, Cebolla A, Khosla C, Sousa C. Toward the assessment of food toxicity for celiac patients: characterization of monoclonal antibodies to a main immunogenic gluten peptide. PLoS One. 2008 May 28;3(5):e2294. doi: 10.1371/journal.pone.0002294.
PubMed 18509534Hausch F, Shan L, Santiago NA, Gray GM, Khosla C. Intestinal digestive resistance of immunodominant gliadin peptides. Am J Physiol Gastrointest Liver Physiol. 2002 Oct;283(4):G996-G1003. doi: 10.1152/ajpgi.00136.2002.
PubMed 12223360Shan L, Molberg O, Parrot I, Hausch F, Filiz F, Gray GM, Sollid LM, Khosla C. Structural basis for gluten intolerance in celiac sprue. Science. 2002 Sep 27;297(5590):2275-9. doi: 10.1126/science.1074129.
PubMed 12351792Comino I, Real A, Vivas S, Siglez MA, Caminero A, Nistal E, Casqueiro J, Rodriguez-Herrera A, Cebolla A, Sousa C. Monitoring of gluten-free diet compliance in celiac patients by assessment of gliadin 33-mer equivalent epitopes in feces. Am J Clin Nutr. 2012 Mar;95(3):670-7. doi: 10.3945/ajcn.111.026708. Epub 2012 Jan 18.
PubMed 22258271
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 0 Monitoring of Gluten-free Diet Compliance in Celiac Patients by Assessment of Gliadin 33-mer Equivalent Epitopes in Feces
- ClinicalTrials.gov ID
- NCT01478867
- Acronym / sponsor ID
- CELIQK2 / CELIQK2
- Conditions
- Celiac Disease
- Keywords
- celiac disease, gluten-free diet, gluten peptides, feces
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Instituto Hispalense de Pediatría, Seville, Spain
- Study start
- Apr 2011
- Study completion
- Jul 2011 (actual)
- First posted
- 23 Nov 2011 (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.
The purpose of this study is to monitor of gluten-free diet compliance in celiac patients by assessment of gliadin 33-mer equivalent epitopes in feces.
Detailed description
Certain immunotoxic peptides from gluten are resistant to gastrointestinal digestion and can interact with celiac patient factors to trigger immunological response. Gluten-free diet (GFD) is the only effective treatment for celiac disease (CD) and its compliance should be monitored to avoid accumulative damage. However, practical methods to monitor diet compliance and to detect the origin of an outbreak of celiac clinical symptoms are not available.
This study assesses the capacity to determine the gluten ingestion, and to monitor the GFD compliance in celiac patients by detection of gluten and gliadin 33-mer equivalent peptidic epitopes in human feces.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Celiac patients | – | Other: Detection of gluten in feces |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Celiac patients, 1-12 years old
Key inclusion criteria (3 listed)
- Celiac patient
- 1-12 years old
- Written informed consent
Key exclusion criteria (2 listed)
- Known inflammatory bowel diseases
- Participation in any other studies involving investigational concomitantly or within two weeks prior to entry into the study and during the course of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection of gluten in fecesAlso: Gluten-free diet, Celiac patientsDetection of Gluten in Feces | Other | Celiac patients |
Primary outcome
Monitoring of gluten-free diet compliance in celiac patients
Time frame: April-July 2011 (3 months)
Usual gluten diet for celiac (home diet not modified for this trial)
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 24 Nov 2011.
- Background: PubMed 18258632Moron B, Cebolla A, Manyani H, Alvarez-Maqueda M, Megias M, Thomas Mdel C, Lopez MC, Sousa C. Sensitive detection of cereal fractions that are toxic to celiac disease patients by using monoclonal antibodies to a main immunogenic wheat peptide. Am J Clin Nutr. 2008 Feb;87(2):405-14. doi: 10.1093/ajcn/87.2.405.
- Background: PubMed 18509534Moron B, Bethune MT, Comino I, Manyani H, Ferragud M, Lopez MC, Cebolla A, Khosla C, Sousa C. Toward the assessment of food toxicity for celiac patients: characterization of monoclonal antibodies to a main immunogenic gluten peptide. PLoS One. 2008 May 28;3(5):e2294. doi: 10.1371/journal.pone.0002294.
- Background: PubMed 12223360Hausch F, Shan L, Santiago NA, Gray GM, Khosla C. Intestinal digestive resistance of immunodominant gliadin peptides. Am J Physiol Gastrointest Liver Physiol. 2002 Oct;283(4):G996-G1003. doi: 10.1152/ajpgi.00136.2002.
- Background: PubMed 12351792Shan L, Molberg O, Parrot I, Hausch F, Filiz F, Gray GM, Sollid LM, Khosla C. Structural basis for gluten intolerance in celiac sprue. Science. 2002 Sep 27;297(5590):2275-9. doi: 10.1126/science.1074129.
- Derived from this study: PubMed 22258271Comino I, Real A, Vivas S, Siglez MA, Caminero A, Nistal E, Casqueiro J, Rodriguez-Herrera A, Cebolla A, Sousa C. Monitoring of gluten-free diet compliance in celiac patients by assessment of gliadin 33-mer equivalent epitopes in feces. Am J Clin Nutr. 2012 Mar;95(3):670-7. doi: 10.3945/ajcn.111.026708. Epub 2012 Jan 18.
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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.
Carolina Sousa, Professor principal investigator
University of Seville
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, run by University of Seville at 1 site in Spain.
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 3 inclusion and 2 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 24 Nov 2011. 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 Spain. 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?
Monitoring of gluten-free diet compliance in celiac patients (time frame: April-July 2011 (3 months)). 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 NCT01478867, which also lists 5 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 24 Nov 2011.