Celiac DiseaseNCT05119322
Use of a Home Test for Gluten Detection in Urine and Its Effect on Gluten-free Diet Adherence
A study testing GlutenDetect home urine test in people with Celiac Disease and Treatment Adherence, run by Biomedal S.L. at 1 site in Spain.
Trial summary
The use of a home rapid test for the detection of gluten immunogenic peptides (GIP) in urine of treated adolescent patients with celiac disease (CD) could facilitate the adherence to the gluten-free diet (GFD) and contribute to symptoms control and quality of life improvement. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Celiac Disease, Treatment Adherence, Adolescent
- What is being tested?
- GlutenDetect home urine test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 23 Mar 2021to 31 Dec 2027
- Phase
- Interventional
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Willingness to take part in the study.
- Signed informed consent.
- Diagnosis of CD confirmed by biopsy and/or serology.
- Ability to: provide urine and stool samples, perform the home tests, and register results.
Who cannot join
- Not precise diagnostic of CD.
- Comorbid condition that in the opinion of the investigator would interfere with the study.
- Lack of willingness to take part in the study.
- Inability to use the test or provide samples.
- Frequent voluntary GFD transgressions.
- To provide less than 70% of the required samples.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Use of a Home Test for the Detection of Gluten Immunogenic Peptides in Urine and Its Effect on Gluten-free Diet Adherence
The use of a home rapid test for the detection of gluten immunogenic peptides (GIP) in urine of treated adolescent patients with celiac disease (CD) could facilitate the adherence to the gluten-free diet (GFD) and contribute to symptoms control and quality of life improvement.
This single centre, randomized, unblinded, controlled study consists of 4 run-in weeks period followed by 8-weeks study period in which patients will be randomized to intervention group (home urine GIP testing) or the control group (no home urine GIP testing). The 12-week study will involve surveys, home stool and urine collection, home urine GIP test performance, and two study visits with the gastroenterologists.
The main outcome is to determine whether the self-monitoring of the GFD with GIP testing in urine improves adherence to the GFD in treated adolescent patients with CD (measured by CDAT-Celiac Dietary Adherence Test, GFD adherence evaluation by gastroenterologist and rates of gluten exposure in urine and/or stool measured at a central laboratory) and subsequently improves quality of life (CDDUX-Coeliac Disease Dutch Questionnaire) and reduces symptoms (CSI-Celiac Symptoms Index questionnaire).
Read the detailed description
Hypothesis: the use of a home rapid test for the detection of gluten immunogenic peptides (GIP) in urine of treated adolescent patients with celiac disease (CD) could facilitate the adherence to the gluten-free diet (GFD) and contribute to symptoms control and quality of life improvement.
Objectives:
Primary objective: to determine in adolescent patients with CD whether the self-monitoring of the GFD with GIP testing in urine changes treatment adherence (intervention group) in comparison with patients that do not use the test (control group) measured by 1 - CDAT-Celiac Dietary Adherence Test; 2 - GFD adherence evaluation by gastroenterologist; 3- Detection rates of GIP in urine and/or stool (to be measured at a central laboratory); 4- Detection rates of GIP in urine (to be measured by home rapid tests).
Secondary objectives: to determine whether the use of the home test for GIP detection in urine samples of treated patients with CD leads to 1 - change of quality of life (CDDUX-Coeliac Disease Dutch Questionnaire); 2- change of symptoms (CSI-Celiac Symptoms Index questionnaire).
Study design: Single centre, randomized, unblinded, controlled, study. The study will consist of 4 run-in weeks period followed by 8-weeks study period in which patients will be randomized to intervention (home urine GIP testing) or the control group (no home urine GIP testing).
Study participants: adolescent patients with CD, diagnosed by European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) guidelines, that have been following a strict GFD for at least 2 years.
Study procedure:
- Patient enrolment.
- Run-in period (4 weeks): all participants will: A- complete quality of life questionnaire (CDDUX); B - complete GFD adherence questionnaire (CDAT); C - complete food diary for 4 consecutive days and GFD adherence will be evaluated by gastroenterologist; D - complete symptom questionnaire (CSI); E - be instructed in the use of the tests and sample collection; F - collect at the beginning and end of the period urine and stool samples.
- Study weeks (8): patients will be randomized to either the control or the study group by block randomization (size 4) using WINPEPI (Programs for epidemiologists for Windows) v11.65 (Abramson, J.H.). The study group will receive home use tests for GFD monitoring to be used at their discretion (but using at least 8 tests during the study period (1/week) so that they may receive immediate qualitative feedback regarding the presence of biomarkers of gluten exposure in their urine and they will have to register the results obtained. The control group will not receive the tests. Additionally, all patients will collect a urine and a stool sample every 4 weeks with the purpose of evaluating their adherence to the GFD. All collected samples will be kept frozen until their analysis and will be brought to the centre by the patients at the end of the study. All samples will be sent to a central laboratory for their analysis (Biomedal S.L., Seville, Spain).
- At the end of the study, patients will be evaluated as in the run-in period (post-intervention).
Number of participants: with an alpha risk of 5%, a beta risk of 20% (80% of statistical power) and an estimated rate reduction of 0.33 the sample size needed was 66 subjects (33 subjects per group). The calculation was made using the tool Calculadora de Grandària Mostral (GRANMO) v7.12 April 2012 (Municipal Institute of Medical Research, Barcelona, Spain).
Measurements: 1- Home rapid test (GlutenDetect, Biomedal S.L., Seville, Spain) for GIP determination in urine samples, laboratory rapid test (iVYCHECK GIP Urine, Biomedal S.L., Seville, Spain) for GIP determination in urine samples and ELISA test (iVYLISA GIP Stool, Biomedal S.L., Seville, Spain) for GIP determination in stool samples; 2- CD related symptoms (CSI questionnaire); 3- quality of life questionnaire (CDDUX); 4- GFD adherence questionnaire (CDAT); 5- GFD adherence evaluation by specialist (questionnaire and food diary); 6 - test results for the study group. Samples will be analysed in a central laboratory (Biomedal S.L., Seville, Spain).
Statistical analysis: Will be done with IBM SPSS Statistics 25.0 for Windows (IBM Corporation, Armonk, New York, United States). 1- Difference in all parameters between and within the control and the study groups. Results will be compared at baseline, week 4 and week 12. 2- Differences in all parameters between patients with positive GIP testing compared to those with negative GIP testing (both home and laboratory GIP measurements). 3 - number of additional tests used by the patients since they will receive 24 tests and they must perform only 8 tests. They can use the additional test at their discretion.
- Conditions
- Celiac Disease, Treatment Adherence, Adolescent
- Being tested
- GlutenDetect home urine test
- Keywords
- Celiac disease, Gluten-free diet adherence, Adolescent, Gluten immunogenic peptides, Urine tests
- Medical subject headings
- Celiac Disease, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutenDetect home urine testDiagnostic test
GFD compliance self-asessment using a home rapid test for GIP detection in urine.
| Study group | Role | What they receive |
|---|---|---|
| GlutenDetect home urine test | Experimental | The GlutenDetect home urine test group will receive home use tests for GIP detection in urine to self-monitor the GFD. Tests will be used at their discretion, but using at least 8 tests during the study period (1/week), so that they may receive immediate qualitative feedback regarding the presence of biomarkers of gluten exposure in their urine and they will have to register the results obtained. Additionally, patients will collect a urine and a stool sample every 4 weeks to evaluate their adherence to the GFD in the laboratory. Receives: Diagnostic Test: GlutenDetect home urine test |
| Control group | No intervention | The control group will not receive any home urine tests but will collect a urine and a stool sample every 4 weeks with the purpose of evaluating their adherence to the GFD in the laboratory. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gluten-free adherence change
Number of participants adherent to GFD in intervention and control arms as assessed by Celiac Dietary Adherence Test (CDAT), change from baseline in scores on the test after 8 weeks of intervention. The scores on the CDAT have a scale from 7 to 35. A score of <13 is considered as good diet adherence and a score >17 is considered as bad diet adherence.
Measured: 8 weeks
Gluten-free adherence change
Number of participants adherent to GFD in intervention and control arms as assessed by GFD adherence evaluation questionnaire by gastroenterologist, change from baseline in level of diet adherence on the questionnaire after 8 weeks of intervention. The scores have a scale from 0 to 32 and social questions (5) have a yes/no answer. A score of 0-7 and "no" in all social questions is considered excellent diet adherence; a score of 8-15 and "no" in all social questions is considered good diet adherence; a score of 8-15 and "yes" in one social question is considered regular diet adherence; a score of 16-24 and "yes" in two social questions is considered regular diet adherence; a score of 16-24 and "yes" in three social questions is considered bad diet adherence; a score of 25-32 and "yes" in two social questions is considered bad diet adherence; a score of 25-32 and "yes" in three social questions is considered very bad diet adherence.
Measured: 8 weeks
Gluten-free adherence change
Number of participants adherent to GFD in intervention and control arms as assessed by detection of GIP in urine and/or stool samples (measured at a central laboratory), change from baseline in GIP qualitative and quantitative results after 8 weeks of intervention.
Measured: 8 weeks
Gluten-free adherence change
Number of participants adherent to GFD in intervention group as assessed by detection of GIP in urine samples (measured by home rapid tests), change from baseline in GIP qualitative results after 8 weeks of intervention.
Measured: 8 weeks
Secondary outcomes (2)
Quality of life change
Number of participants with affected quality of life in intervention and control arms as assessed by Coeliac Disease Dutch Questionnaire (CDDUX), change from baseline in scores from after 8 weeks of intervention. The scores on the CDDUX are recoded into a scale from 1 to 100. A score of 1-20 is considered very bad, 21-40 is bad, 41-60 is neutral, 61-80 is good, and 81 to 100 is very good.
Measured: 8 weeks
Symptoms change
Number of participants with CD symptoms in intervention and control arms as assessed by Celiac Symptoms Index questionnaire (CSI), change from baseline in symptom scores after 8 weeks of intervention. The scores on the CSI are recoded into a scale from 16 to 80. A score of ≥38 is considered as symptomatic.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start23 Mar 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2027 (estimated)
Why it stopped: lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention and control groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biomedal S.L.
- Sponsor type
- University, hospital or other
- Collaborators
- FUNDACION IHP
- Responsible party
- Sponsor
- Investigators
- Laura Coto Alonso, Principal investigator, Biomedal S.L.Ángel Cebolla Ramírez, Study director, Biomedal S.L.Joaquín Reyes Andrade, Principal investigator, Fundación IHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119322
- Sponsor's protocol ID
- GLUTENDETECT
- Status last verified
- Apr 2024
- First submitted
- 26 Oct 2021
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 22258271Moreno 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 26608460Gerasimidis K, Zafeiropoulou K, Mackinder M, Ijaz UZ, Duncan H, Buchanan E, Cardigan T, Edwards CA, McGrogan P, Russell RK. Comparison of Clinical Methods With the Faecal Gluten Immunogenic Peptide to Assess Gluten Intake in Coeliac Disease. J Pediatr Gastroenterol Nutr. 2018 Sep;67(3):356-360. doi: 10.1097/MPG.0000000000002062.
PubMed 29916953Comino 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 27644734Costa AF, Sugai E, Temprano MP, Niveloni SI, Vazquez H, Moreno ML, Dominguez-Flores MR, Munoz-Suano A, Smecuol E, Stefanolo JP, Gonzalez AF, Cebolla-Ramirez A, Maurino E, Verdu EF, Bai JC. Gluten immunogenic peptide excretion detects dietary transgressions in treated celiac disease patients. World J Gastroenterol. 2019 Mar 21;25(11):1409-1420. doi: 10.3748/wjg.v25.i11.1409.
PubMed 30918433Comino 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 31074004
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
- Study of the Use of a Home Test for the Detection of Gluten Immunogenic Peptides in Urine and Its Effect on Gluten-free Diet Adherence
- ClinicalTrials.gov ID
- NCT05119322
- Acronym / sponsor ID
- GLUTENDETECT
- Conditions
- Celiac Disease, Treatment Adherence, Adolescent
- Keywords
- Celiac disease, Gluten-free diet adherence, Adolescent, Gluten immunogenic peptides, Urine tests
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: lack of resources
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Biomedal S.L.University, hospital or other
- Collaborators
- FUNDACION IHP
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Nov 2021 (actual)
- 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 use of a home rapid test for the detection of gluten immunogenic peptides (GIP) in urine of treated adolescent patients with celiac disease (CD) could facilitate the adherence to the gluten-free diet (GFD) and contribute to symptoms control and quality of life improvement.
This single centre, randomized, unblinded, controlled study consists of 4 run-in weeks period followed by 8-weeks study period in which patients will be randomized to intervention group (home urine GIP testing) or the control group (no home urine GIP testing). The 12-week study will involve surveys, home stool and urine collection, home urine GIP test performance, and two study visits with the gastroenterologists.
The main outcome is to determine whether the self-monitoring of the GFD with GIP testing in urine improves adherence to the GFD in treated adolescent patients with CD (measured by CDAT-Celiac Dietary Adherence Test, GFD adherence evaluation by gastroenterologist and rates of gluten exposure in urine and/or stool measured at a central laboratory) and subsequently improves quality of life (CDDUX-Coeliac Disease Dutch Questionnaire) and reduces symptoms (CSI-Celiac Symptoms Index questionnaire).
Detailed description
Hypothesis: the use of a home rapid test for the detection of gluten immunogenic peptides (GIP) in urine of treated adolescent patients with celiac disease (CD) could facilitate the adherence to the gluten-free diet (GFD) and contribute to symptoms control and quality of life improvement.
Objectives:
Primary objective: to determine in adolescent patients with CD whether the self-monitoring of the GFD with GIP testing in urine changes treatment adherence (intervention group) in comparison with patients that do not use the test (control group) measured by 1 - CDAT-Celiac Dietary Adherence Test; 2 - GFD adherence evaluation by gastroenterologist; 3- Detection rates of GIP in urine and/or stool (to be measured at a central laboratory); 4- Detection rates of GIP in urine (to be measured by home rapid tests).
Secondary objectives: to determine whether the use of the home test for GIP detection in urine samples of treated patients with CD leads to 1 - change of quality of life (CDDUX-Coeliac Disease Dutch Questionnaire); 2- change of symptoms (CSI-Celiac Symptoms Index questionnaire).
Study design: Single centre, randomized, unblinded, controlled, study. The study will consist of 4 run-in weeks period followed by 8-weeks study period in which patients will be randomized to intervention (home urine GIP testing) or the control group (no home urine GIP testing).
Study participants: adolescent patients with CD, diagnosed by European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) guidelines, that have been following a strict GFD for at least 2 years.
Study procedure:
- Patient enrolment.
- Run-in period (4 weeks): all participants will: A- complete quality of life questionnaire (CDDUX); B - complete GFD adherence questionnaire (CDAT); C - complete food diary for 4 consecutive days and GFD adherence will be evaluated by gastroenterologist; D - complete symptom questionnaire (CSI); E - be instructed in the use of the tests and sample collection; F - collect at the beginning and end of the period urine and stool samples.
- Study weeks (8): patients will be randomized to either the control or the study group by block randomization (size 4) using WINPEPI (Programs for epidemiologists for Windows) v11.65 (Abramson, J.H.). The study group will receive home use tests for GFD monitoring to be used at their discretion (but using at least 8 tests during the study period (1/week) so that they may receive immediate qualitative feedback regarding the presence of biomarkers of gluten exposure in their urine and they will have to register the results obtained. The control group will not receive the tests. Additionally, all patients will collect a urine and a stool sample every 4 weeks with the purpose of evaluating their adherence to the GFD. All collected samples will be kept frozen until their analysis and will be brought to the centre by the patients at the end of the study. All samples will be sent to a central laboratory for their analysis (Biomedal S.L., Seville, Spain).
- At the end of the study, patients will be evaluated as in the run-in period (post-intervention).
Number of participants: with an alpha risk of 5%, a beta risk of 20% (80% of statistical power) and an estimated rate reduction of 0.33 the sample size needed was 66 subjects (33 subjects per group). The calculation was made using the tool Calculadora de Grandària Mostral (GRANMO) v7.12 April 2012 (Municipal Institute of Medical Research, Barcelona, Spain).
Measurements: 1- Home rapid test (GlutenDetect, Biomedal S.L., Seville, Spain) for GIP determination in urine samples, laboratory rapid test (iVYCHECK GIP Urine, Biomedal S.L., Seville, Spain) for GIP determination in urine samples and ELISA test (iVYLISA GIP Stool, Biomedal S.L., Seville, Spain) for GIP determination in stool samples; 2- CD related symptoms (CSI questionnaire); 3- quality of life questionnaire (CDDUX); 4- GFD adherence questionnaire (CDAT); 5- GFD adherence evaluation by specialist (questionnaire and food diary); 6 - test results for the study group. Samples will be analysed in a central laboratory (Biomedal S.L., Seville, Spain).
Statistical analysis: Will be done with IBM SPSS Statistics 25.0 for Windows (IBM Corporation, Armonk, New York, United States). 1- Difference in all parameters between and within the control and the study groups. Results will be compared at baseline, week 4 and week 12. 2- Differences in all parameters between patients with positive GIP testing compared to those with negative GIP testing (both home and laboratory GIP measurements). 3 - number of additional tests used by the patients since they will receive 24 tests and they must perform only 8 tests. They can use the additional test at their discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention and control groups
| Arm | Type | Receives |
|---|---|---|
| GlutenDetect home urine test | Experimental | Diagnostic Test: GlutenDetect home urine testThe GlutenDetect home urine test group will receive home use tests for GIP detection in urine to self-monitor the GFD. Tests will be used at their discretion, but using at least 8 tests during the study period (1/week), so that they may receive immediate qualitative feedback regarding the presence of biomarkers of gluten exposure in their urine and they will have to register the results obtained. Additionally, patients will collect a urine and a stool sample every 4 weeks to evaluate their adherence to the GFD in the laboratory. |
| Control group | No intervention | –The control group will not receive any home urine tests but will collect a urine and a stool sample every 4 weeks with the purpose of evaluating their adherence to the GFD in the laboratory. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Willingness to take part in the study.
- Signed informed consent.
- Diagnosis of CD confirmed by biopsy and/or serology.
- Ability to: provide urine and stool samples, perform the home tests, and register results.
Key exclusion criteria (6 listed)
- Not precise diagnostic of CD.
- Comorbid condition that in the opinion of the investigator would interfere with the study.
- Lack of willingness to take part in the study.
- Inability to use the test or provide samples.
- Frequent voluntary GFD transgressions.
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 |
|---|---|---|
| GlutenDetect home urine testGFD compliance self-asessment using a home rapid test for GIP detection in urine. | Diagnostic test | GlutenDetect home urine test |
Primary outcome
Gluten-free adherence change
Time frame: 8 weeks
Number of participants adherent to GFD in intervention and control arms as assessed by Celiac Dietary Adherence Test (CDAT), change from baseline in scores on the test after 8 weeks of intervention. The scores on the CDAT have a scale from 7 to 35. A score of <13 is considered as good diet adherence and a score >17 is considered as bad diet adherence.
Gluten-free adherence change
Time frame: 8 weeks
Number of participants adherent to GFD in intervention and control arms as assessed by GFD adherence evaluation questionnaire by gastroenterologist, change from baseline in level of diet adherence on the questionnaire after 8 weeks of intervention. The scores have a scale from 0 to 32 and social questions (5) have a yes/no answer. A score of 0-7 and "no" in all social questions is considered excellent diet adherence; a score of 8-15 and "no" in all social questions is considered good diet adherence; a score of 8-15 and "yes" in one social question is considered regular diet adherence; a score of 16-24 and "yes" in two social questions is considered regular diet adherence; a score of 16-24 and "yes" in three social questions is considered bad diet adherence; a score of 25-32 and "yes" in two social questions is considered bad diet adherence; a score of 25-32 and "yes" in three social questions is considered very bad diet adherence.
Gluten-free adherence change
Time frame: 8 weeks
Number of participants adherent to GFD in intervention and control arms as assessed by detection of GIP in urine and/or stool samples (measured at a central laboratory), change from baseline in GIP qualitative and quantitative results after 8 weeks of intervention.
Gluten-free adherence change
Time frame: 8 weeks
Number of participants adherent to GFD in intervention group as assessed by detection of GIP in urine samples (measured by home rapid tests), change from baseline in GIP qualitative results after 8 weeks of intervention.
2 secondary outcomes
Quality of life change
Time frame: 8 weeks
Symptoms change
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- 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 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.
- Background: PubMed 29916953Gerasimidis K, Zafeiropoulou K, Mackinder M, Ijaz UZ, Duncan H, Buchanan E, Cardigan T, Edwards CA, McGrogan P, Russell RK. Comparison of Clinical Methods With the Faecal Gluten Immunogenic Peptide to Assess Gluten Intake in Coeliac Disease. J Pediatr Gastroenterol Nutr. 2018 Sep;67(3):356-360. doi: 10.1097/MPG.0000000000002062.
- Background: 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.
- Background: PubMed 30918433Costa AF, Sugai E, Temprano MP, Niveloni SI, Vazquez H, Moreno ML, Dominguez-Flores MR, Munoz-Suano A, Smecuol E, Stefanolo JP, Gonzalez AF, Cebolla-Ramirez A, Maurino E, Verdu EF, Bai JC. Gluten immunogenic peptide excretion detects dietary transgressions in treated celiac disease patients. World J Gastroenterol. 2019 Mar 21;25(11):1409-1420. doi: 10.3748/wjg.v25.i11.1409.
- Background: 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.
- GlutenDetect websiteLink provided by the sponsor.
- iVYDAL websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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
Celiac Disease
RecruitingObservational study
Pathogenic Study of Adult Immune Enteropathies
Celiac Disease, Autoimmune Enteropathy
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.
Laura Coto Alonso principal investigator
Biomedal S.L.
Ángel Cebolla Ramírez study director
Biomedal S.L.
Joaquín Reyes Andrade principal investigator
Fundación IHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GlutenDetect home urine test in people with Celiac Disease and Treatment Adherence, run by Biomedal S.L. 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 4 inclusion and 6 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: paused, 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.
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?
Results are not available in the source record.
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?
Gluten-free adherence change (time frame: 8 weeks). The study lists 4 primary outcomes in all. 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 NCT05119322, which also lists 6 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.