Celiac DiseaseEarly Phase 1NCT02344758

Gluten-free Diet Monitoring in Urine

A Early Phase 1 study testing Non-invasive lateral flow test for monitoring gluten intake, gluten-free diet (GFD) and gluten-containing diet in people with Celiac Disease, run by University of Seville at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to develope a novel method to determine gluten intake and to check gluten-free diet adherence in celiac patients by detection of gluten immunogenic peptides in urine. Read more about this study

Who is it for?: Ages 3 years and older
Conditions the study is for: Celiac Disease
What is being tested?: Non-invasive lateral flow test for monitoring gluten intake, gluten-free diet (GFD) and gluten-containing diet
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 134 participants
Where: 1 siteSpain
Study dates: Apr 2013to Dec 2013
Phase: Early Phase 1
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 3 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Celiac patient: childs (< 16 years) and adults (> 16 years)
written informed consent

Who cannot join

presence of family history of CD
digestive disease symptoms
known medical disease
use of prescription medications and use of antibiotics and probiotics in the previous 2 months to the inclusion in the study
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

Other trials in Spain

About this study

Official title: Non-invasive Gluten-free Diet Adherence Monitoring in Celiac Patients: Detection of Gluten Immunogenic Peptides in Urine

The purpose of this study is to develope a novel method to determine gluten intake and to check gluten-free diet adherence in celiac patients by detection of gluten immunogenic peptides in urine.

Read the detailed description

To date, the mainstay of the management of CD is a strict life-long adherence to gluten-free diet (GFD). Follow-up monitoring of the improvement of patients on GFD is essential to assess symptomatic recovery and to monitor complications, as well as to assist patients with dietary compliance. However, practical methods to monitor diet compliance and to detect the origin of an outbreak of celiac clinical symptoms are not available.

In this study, we have overcome these challenges and shown the feasibility of measuring gluten immunogenic peptides (GIP) in urine samples in healthy and celiac individuals by solid phase extraction and estimating the peptide concentrations with a reader of anti-GIP moAb immunochromatographic strips (IC-strips).

Conditions: Celiac Disease
Being tested: Non-invasive lateral flow test for monitoring gluten intake, gluten-free diet (GFD), gluten-containing diet
Medical subject headings: Celiac Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Non-invasive lateral flow test for monitoring gluten intakeDevice
gluten-free diet (GFD)Behavioural
gluten-containing dietBehavioural

Study groups in NCT02344758
Study group	Role	What they receive
Celiac adult	Experimental	Patient >16 years, initially diagnosed based on the detection of IgA anti-endomysial and anti-tissue transglutaminase antibodies in serum and confirmed by a small intestinal biopsy, on a GFD for >2 years Receives: Device: Non-invasive lateral flow test for monitoring gluten intake; Behavioral: gluten-free diet (GFD)
Celiac child	Experimental	Patient <16 years, initially diagnosed based on the detection of IgA anti-endomysial and anti-tissue transglutaminase antibodies in serum and confirmed by a small intestinal biopsy, on a GFD for >2 years Receives: Device: Non-invasive lateral flow test for monitoring gluten intake; Behavioral: gluten-free diet (GFD)
Healthy adult	Active comparator	Healthy individual > 16 years. Exclusion criteria: the presence of family history of CD, digestive disease symptoms, known medical disease, use of prescription medications, and use of antibiotics and probiotics in the previous 2 months to the inclusion in the study. Receives: Device: Non-invasive lateral flow test for monitoring gluten intake; Behavioral: gluten-containing diet
Healthy child	Active comparator	Healthy individual < 16 years. Exclusion criteria: the presence of family history of CD, digestive disease symptoms, known medical disease, use of prescription medications, and use of antibiotics and probiotics in the previous 2 months to the inclusion in the study. Receives: Device: Non-invasive lateral flow test for monitoring gluten intake; Behavioral: gluten-containing diet

What is being measured

The primary outcome is the main question the study is designed to answer.

Usual gluten-containing diet for healthy individuals
Measured: 1 month

Secondary outcomes (1)

Usual gluten-free diet for celiac patients (home diet not modified for this trial)
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Dec 2013

First posted26 Jan 2015 (estimated)
Study startApr 2013
Primary completionJul 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)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: Interventional
Phase: Early Phase 1
Allocation: Randomised
Intervention model: Parallel groups
Enrolment: 134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02344758
Sponsor's protocol ID: CELIFLUID1
Status last verified: Jan 2015
First submitted: 14 Jan 2015
Last updated: 26 Jan 2015
Results posted: No
Data monitoring committee: Yes

Publications

Moron 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 18509534
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 18258632
Hausch 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 12223360
Shan 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 12351792
Comino 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
Comino I, Real A, Moreno Mde L, Montes R, Cebolla A, Sousa C. Immunological determination of gliadin 33-mer equivalent peptides in beers as a specific and practical analytical method to assess safety for celiac patients. J Sci Food Agric. 2013 Mar 15;93(4):933-43. doi: 10.1002/jsfa.5830. Epub 2012 Aug 6.
PubMed 22886585
Real A, Comino I, Moreno Mde L, Lopez-Casado MA, Lorite P, Torres MI, Cebolla A, Sousa C. Identification and in vitro reactivity of celiac immunoactive peptides in an apparent gluten-free beer. PLoS One. 2014 Jun 25;9(6):e100917. doi: 10.1371/journal.pone.0100917. eCollection 2014.
PubMed 24963630
Moreno ML, Cebolla A, Munoz-Suano A, Carrillo-Carrion C, Comino I, Pizarro A, Leon F, Rodriguez-Herrera A, Sousa C. Detection of gluten immunogenic peptides in the urine of patients with coeliac disease reveals transgressions in the gluten-free diet and incomplete mucosal healing. Gut. 2017 Feb;66(2):250-257. doi: 10.1136/gutjnl-2015-310148. Epub 2015 Nov 25.
PubMed 26608460

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Celiac Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-invasive Gluten-free Diet Adherence Monitoring in Celiac Patients: Detection of Gluten Immunogenic Peptides in Urine
ClinicalTrials.gov ID: NCT02344758
Acronym / sponsor ID: CELIFLUID1
Conditions: Celiac Disease
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 134 participants (actual)
Lead sponsor: University of SevilleUniversity, hospital or other
Collaborators: Instituto Hispalense de Pediatría, Hospitales Universitarios Virgen del Rocío
Study start: Apr 2013
Primary completion: Jul 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 26 Jan 2015 (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 develope a novel method to determine gluten intake and to check gluten-free diet adherence in celiac patients by detection of gluten immunogenic peptides in urine.

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Number of arms: 4

Arm	Type	Receives
Celiac adult	Experimental	Device: Non-invasive lateral flow test for monitoring gluten intake, Behavioral: gluten-free diet (GFD)Patient >16 years, initially diagnosed based on the detection of IgA anti-endomysial and anti-tissue transglutaminase antibodies in serum and confirmed by a small intestinal biopsy, on a GFD for >2 years
Celiac child	Experimental	Device: Non-invasive lateral flow test for monitoring gluten intake, Behavioral: gluten-free diet (GFD)Patient <16 years, initially diagnosed based on the detection of IgA anti-endomysial and anti-tissue transglutaminase antibodies in serum and confirmed by a small intestinal biopsy, on a GFD for >2 years
Healthy adult	Active comparator	Device: Non-invasive lateral flow test for monitoring gluten intake, Behavioral: gluten-containing dietHealthy individual > 16 years. Exclusion criteria: the presence of family history of CD, digestive disease symptoms, known medical disease, use of prescription medications, and use of antibiotics and probiotics in the previous 2 months to the inclusion in the study.
Healthy child	Active comparator	Device: Non-invasive lateral flow test for monitoring gluten intake, Behavioral: gluten-containing dietHealthy individual < 16 years. Exclusion criteria: the presence of family history of CD, digestive disease symptoms, known medical disease, use of prescription medications, and use of antibiotics and probiotics in the previous 2 months to the inclusion in the study.

Who may qualify

Ages: 3 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Celiac patient: childs (< 16 years) and adults (> 16 years)
written informed consent

Key exclusion criteria (5 listed)

presence of family history of CD
digestive disease symptoms
known medical disease
use of prescription medications and use of antibiotics and probiotics in the previous 2 months to the inclusion in the study
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
Non-invasive lateral flow test for monitoring gluten intake	Device	Celiac adult, Celiac child, Healthy adult, Healthy child
gluten-free diet (GFD)	Behavioural	Celiac adult, Celiac child
gluten-containing diet	Behavioural	Healthy adult, Healthy child

Primary outcome

Usual gluten-containing diet for healthy individuals
Time frame: 1 month

1 secondary outcome

Usual gluten-free diet for celiac patients (home diet not modified for this trial)
Time frame: 1 month

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 26 Jan 2015.
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 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 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.
Background: 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.
Background: PubMed 22886585Comino I, Real A, Moreno Mde L, Montes R, Cebolla A, Sousa C. Immunological determination of gliadin 33-mer equivalent peptides in beers as a specific and practical analytical method to assess safety for celiac patients. J Sci Food Agric. 2013 Mar 15;93(4):933-43. doi: 10.1002/jsfa.5830. Epub 2012 Aug 6.
Background: PubMed 24963630Real A, Comino I, Moreno Mde L, Lopez-Casado MA, Lorite P, Torres MI, Cebolla A, Sousa C. Identification and in vitro reactivity of celiac immunoactive peptides in an apparent gluten-free beer. PLoS One. 2014 Jun 25;9(6):e100917. doi: 10.1371/journal.pone.0100917. eCollection 2014.
Derived from this study: PubMed 26608460Moreno ML, Cebolla A, Munoz-Suano A, Carrillo-Carrion C, Comino I, Pizarro A, Leon F, Rodriguez-Herrera A, Sousa C. Detection of gluten immunogenic peptides in the urine of patients with coeliac disease reveals transgressions in the gluten-free diet and incomplete mucosal healing. Gut. 2017 Feb;66(2):250-257. doi: 10.1136/gutjnl-2015-310148. Epub 2015 Nov 25.

Related trials for Celiac Disease

Active, not recruitingEarly Phase 1
VTP-1000 in Adults With Celiac Disease
Celiac Disease
RecruitingObservational study
Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
Celiac Disease, Gluten-free Diet
Recruiting
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Celiac Disease in Children, Nutrition Disorder, Child
RecruitingObservational study
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
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RecruitingObservational study
Pathogenic Study of Adult Immune Enteropathies
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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.

Mª de Lourdes Moreno Amador, Dr study chair

Department of Microbiology and Parasitology, University of Sevilla, Spain

Ángel Cebolla Ramírez, Dr study chair

Biomedal S.L.

Ángeles Pizarro Moreno, Dr study chair

Unidad Clínica de Aparato Digestivo, Hospital Universitario Virgen del Rocío, Sevilla, Spain

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 5 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 26 Jan 2015. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Usual gluten-containing diet for healthy individuals (time frame: 1 month). 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 NCT02344758, which also lists 8 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 26 Jan 2015.