Celiac DiseaseDELIACNCT02711397
Quantification of Gluten Peptides in Feces
An observational study of Celiac Disease, run by Biomedal S.L..
Trial summary
Treatment for celiac disease (CD) is a lifelong strict gluten-free diet (GFD). Patients should be followed-up with dietary interviews and serologic tests for CD markers to ensure adherence to the diet. However, none of these methods offer an accurate measure of dietary compliance. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Observational study
- How many people
- 272 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Jun 2014
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Celiac patients following a GFD for at least one year prior to the inclusion in the study
Who may be able to join
- The study group consisted of celiac patients following a GFD for at least one year prior to the inclusion in the study and they were required to have an HLA-DQ2 or HLA-DQ8 haplotype and an histologically abnormal duodenal biopsy (grade Marsh IIIB or IIIC) at the time of diagnosis, supported by positive serum anti-endomysium IgA antibodies and/or anti-tissue transglutaminase (anti-tTG) IgA antibodies.
- The positive and negative control groups was comprised of healthy asymptomatic subjects in whom CD had been ruled out and who were not suspected of having any other gastrointestinal condition
Who cannot join
- All study patients included history of kidney or liver disease, and history of severe psychiatric disease or seizure disorder.
About this study
Official title: Fecal Gluten Peptides Reveal Limitations of Serological Tests and Food Questionnaires for Monitoring Gluten-free Diet
Treatment for celiac disease (CD) is a lifelong strict gluten-free diet (GFD). Patients should be followed-up with dietary interviews and serologic tests for CD markers to ensure adherence to the diet. However, none of these methods offer an accurate measure of dietary compliance. Our aim was to evaluate the measurement of gluten immunogenic peptides (GIP) in stools as a marker of GFD adherence in CD patients and compare it with traditional methods of GFD monitoring.
We performed a prospective, non-randomized, multicentre study including 188 CD patients on a GFD and 73 healthy controls on a gluten-containing diet. Subjects were given a dietary questionnaire and fecal GIP quantified by ELISA (iVYLISA GIP-S kit). Serological anti-tissue transglutaminase (anti-tTG) IgA and anti-deamidated gliadin peptide (anti-DGP) IgA antibodies were measured simultaneously.
- Conditions
- Celiac Disease
- Being tested
- Observational study
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Comparison excretion levels of gluten immunogenic peptides
| Study group | Role | What they receive |
|---|---|---|
| Celiac patients | Celiac patients following a GFD for at least one year prior to the inclusion in the study. Receives: Other: Observational study | |
| Positive controls | Healthy children and adults on an unrestricted gluten containing diet. Receives: Other: Observational study | |
| Negative controls | Healthy infants who were exclusively fed with infant formula specifically labelled as gluten-free. Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to gluten-free diet
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startApr 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomedal S.L.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carolina Sousa, PhD, Study director, Department of Microbiology and Parasitology, Faculty of Pharmacy, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711397
- Sponsor's protocol ID
- DELIAC
- Acronym
- DELIAC
- Status last verified
- Mar 2016
- First submitted
- 14 Mar 2016
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Comino I, Segura V, Ortigosa L, Espin B, Castillejo G, Garrote JA, Sierra C, Millan A, Ribes-Koninckx C, Roman E, Rodriguez-Herrera A, Diaz J, Silvester JA, Cebolla A, Sousa C. Prospective longitudinal study: use of faecal gluten immunogenic peptides to monitor children diagnosed with coeliac disease during transition to a gluten-free diet. Aliment Pharmacol Ther. 2019 Jun;49(12):1484-1492. doi: 10.1111/apt.15277. Epub 2019 May 10.
PubMed 31074004Comino I, Fernandez-Banares F, Esteve M, Ortigosa L, Castillejo G, Fambuena B, Ribes-Koninckx C, Sierra C, Rodriguez-Herrera A, Salazar JC, Caunedo A, Marugan-Miguelsanz JM, Garrote JA, Vivas S, Lo Iacono O, Nunez A, Vaquero L, Vegas AM, Crespo L, Fernandez-Salazar L, Arranz E, Jimenez-Garcia VA, Antonio Montes-Cano M, Espin B, Galera A, Valverde J, Giron FJ, Bolonio M, Millan A, Cerezo FM, Guajardo C, Alberto JR, Rosinach M, Segura V, Leon F, Marinich J, Munoz-Suano A, Romero-Gomez M, Cebolla A, Sousa C. Fecal Gluten Peptides Reveal Limitations of Serological Tests and Food Questionnaires for Monitoring Gluten-Free Diet in Celiac Disease Patients. Am J Gastroenterol. 2016 Oct;111(10):1456-1465. doi: 10.1038/ajg.2016.439. Epub 2016 Sep 20.
PubMed 27644734
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Gluten Peptides Reveal Limitations of Serological Tests and Food Questionnaires for Monitoring Gluten-free Diet
- ClinicalTrials.gov ID
- NCT02711397
- Acronym / sponsor ID
- DELIAC / DELIAC
- Conditions
- Celiac Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Biomedal S.L.University, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Mar 2016 (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.
Treatment for celiac disease (CD) is a lifelong strict gluten-free diet (GFD). Patients should be followed-up with dietary interviews and serologic tests for CD markers to ensure adherence to the diet. However, none of these methods offer an accurate measure of dietary compliance. Our aim was to evaluate the measurement of gluten immunogenic peptides (GIP) in stools as a marker of GFD adherence in CD patients and compare it with traditional methods of GFD monitoring.
We performed a prospective, non-randomized, multicentre study including 188 CD patients on a GFD and 73 healthy controls on a gluten-containing diet. Subjects were given a dietary questionnaire and fecal GIP quantified by ELISA (iVYLISA GIP-S kit). Serological anti-tissue transglutaminase (anti-tTG) IgA and anti-deamidated gliadin peptide (anti-DGP) IgA antibodies were measured simultaneously.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Celiac patients | – | Other: Observational studyCeliac patients following a GFD for at least one year prior to the inclusion in the study. |
| Positive controls | – | Other: Observational studyHealthy children and adults on an unrestricted gluten containing diet. |
| Negative controls | – | Other: Observational studyHealthy infants who were exclusively fed with infant formula specifically labelled as gluten-free. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Celiac patients following a GFD for at least one year prior to the inclusion in the study
Key inclusion criteria (2 listed)
- The study group consisted of celiac patients following a GFD for at least one year prior to the inclusion in the study and they were required to have an HLA-DQ2 or HLA-DQ8 haplotype and an histologically abnormal duodenal biopsy (grade Marsh IIIB or IIIC) at the time of diagnosis, supported by positive serum anti-endomysium IgA antibodies and/or anti-tissue transglutaminase (anti-tTG) IgA antibodies.
- The positive and negative control groups was comprised of healthy asymptomatic subjects in whom CD had been ruled out and who were not suspected of having any other gastrointestinal condition
Key exclusion criteria (1 listed)
- All study patients included history of kidney or liver disease, and history of severe psychiatric disease or seizure disorder.
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 |
|---|---|---|
| Observational studyComparison excretion levels of gluten immunogenic peptides | Other | Celiac patients, Negative controls, Positive controls |
Primary outcome
Adherence to gluten-free diet
Time frame: two years
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 29 Apr 2024.
- Derived from this study: PubMed 31074004Comino I, Segura V, Ortigosa L, Espin B, Castillejo G, Garrote JA, Sierra C, Millan A, Ribes-Koninckx C, Roman E, Rodriguez-Herrera A, Diaz J, Silvester JA, Cebolla A, Sousa C. Prospective longitudinal study: use of faecal gluten immunogenic peptides to monitor children diagnosed with coeliac disease during transition to a gluten-free diet. Aliment Pharmacol Ther. 2019 Jun;49(12):1484-1492. doi: 10.1111/apt.15277. Epub 2019 May 10.
- Derived from this study: PubMed 27644734Comino I, Fernandez-Banares F, Esteve M, Ortigosa L, Castillejo G, Fambuena B, Ribes-Koninckx C, Sierra C, Rodriguez-Herrera A, Salazar JC, Caunedo A, Marugan-Miguelsanz JM, Garrote JA, Vivas S, Lo Iacono O, Nunez A, Vaquero L, Vegas AM, Crespo L, Fernandez-Salazar L, Arranz E, Jimenez-Garcia VA, Antonio Montes-Cano M, Espin B, Galera A, Valverde J, Giron FJ, Bolonio M, Millan A, Cerezo FM, Guajardo C, Alberto JR, Rosinach M, Segura V, Leon F, Marinich J, Munoz-Suano A, Romero-Gomez M, Cebolla A, Sousa C. Fecal Gluten Peptides Reveal Limitations of Serological Tests and Food Questionnaires for Monitoring Gluten-Free Diet in Celiac Disease Patients. Am J Gastroenterol. 2016 Oct;111(10):1456-1465. doi: 10.1038/ajg.2016.439. Epub 2016 Sep 20.
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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, PhD study director
Department of Microbiology and Parasitology, Faculty of Pharmacy, University of Seville
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by Biomedal S.L..
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 1 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 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Adherence to gluten-free diet (time frame: two years). 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 NCT02711397, which also lists 2 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 29 Apr 2024.