Celiac DiseaseNCT04477239
Diagnostic Performance of Urinary Gluten Immunogenic Peptides in Monitoring the Adherence to Gluten-free Diet.
A study testing Gluten (behaviour) in people with Celiac Disease, run by Università Politecnica delle Marche at 1 site in Italy.
Trial summary
The purpose of the GRRES study is to assess the clinical usefulness of urinary gluten immunogenic peptides test as a marker of gluten-free diet adherence using the rapid immunochromatographic assay based on anti-gliadin 33-mer monoclonal antibodies. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Gluten (behaviour)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2020to 31 Dec 2020
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
- 20-40 years old
- written informed consent
Who cannot join
- type 1 diabetes
- chronic or acute inflammatory diseases of the gastrointestinal tract (CD, non-celiac gluten sensitivity, Crohn's disease, ulcerative colitis, food allergy, acute gastroenteritis ≤ 4 weeks prior to the study start)
- pregnancy or lactation
- chronic intake of medications and supplements
- refusal/withdrawal of written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Triple-blind, Placebo-controlled, Clinical Trial on the Diagnostic Performance of Gluten Immunogenic Peptides in the Evaluation of Gluten-free Diet Adherence: the GRRES Study.
The purpose of the GRRES study is to assess the clinical usefulness of urinary gluten immunogenic peptides test as a marker of gluten-free diet adherence using the rapid immunochromatographic assay based on anti-gliadin 33-mer monoclonal antibodies.
Read the detailed description
A strict and permanent gluten free diet (GFD) is the only effective treatment resulting in full clinical, serological and histological remission, avoiding long-term complications in celiac disease (CD) patients. Gluten immunogenic peptides (GIP) are fragments of gluten proteins resistant to gastrointestinal digestion and detectable in urine after intestinal digestion, providing direct evidence of recent gluten ingestion. A significant variability in the amount of excreted urinary GIP has been reported in individuals administered with similar doses of gluten and, so far, inadequate information is available about the amount of excreted GIP in subjects ingesting traces or low amount of gluten. This is an important issue, as even a strict GFD could be contaminated by traces of gluten, e.g. in wheat starch and processed food. The aim of this study is to assess the clinical usefulness of urinary GIP as a marker of GFD adherence using a rapid immunochromatographic assay based on anti-gliadin 33-mer monoclonal antibodies. This is a prospective, randomized, triple-blind, placebo-controlled, clinical trial. In this study, healthy volunteers following a normal diet will be requested to be on strict GFD for 5 days. On day 4th, participants will be requested to collect a baseline urine sample and in case of a negative GIP test result they will be assigned to ingest a specific dose of purified gluten incorporated in a capsule (0 mg, 10 mg, 50 mg, 100 mg, 500 mg and 1000 mg, according to randomization). Participants will be requested to collect urine samples in a container and take a 5 mL aliquote for the GIP test at the 9th and 24th hour from the time of the administration of the dose. During the collection, volunteers will also be requested to record the volume of the excreted urine and to store the collected urine at 4°C. Urine tubes will be stored at -20°C until the quantitative evaluation of GIP. GIP test will be performed using the rapid immunochromatographic assay based on anti-gliadin 33-mer monoclonal antibodies iVYCHECK GIP Urine™ test (Biomedal, Spain) according to the manufacturer's instructions.
- Conditions
- Celiac Disease
- Being tested
- Gluten (behaviour), Placebo (behaviour)
- Keywords
- Gluten-free diet, Gluten immunogenic peptides, Gluten contamination, Gluten, Urine
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten (behaviour)Behavioural
Gluten is a protein normally present in the daily diet of healthy volunteers not suffering from gluten related disorders, in far greater quantities (10-20 g/day) than those used in this study (10 mg-1 g/day).
Placebo (behaviour)Behavioural
Placebo is composed of pregelatinized maize starch Ph.Eur. 97.5%; magnesium stearate Ph.Eur. 1.5%; micronized silica Ph.Eur. 0.5%; Micronized talc Ph.Eur. 0.5% (NOT containing preservatives, colorings, or gluten).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Oral administration of one capsule of Placebo Receives: Behavioral: Gluten (behaviour); Behavioral: Placebo (behaviour) |
| Purified gluten (10 mg) | Active comparator | Oral administration of capsules containing 10 mg of purified gluten. Receives: Behavioral: Gluten (behaviour); Behavioral: Placebo (behaviour) |
| Purified gluten (50 mg) | Active comparator | Oral administration of capsules containing 50 mg of purified gluten. Receives: Behavioral: Gluten (behaviour); Behavioral: Placebo (behaviour) |
| Purified gluten (100 mg) | Active comparator | Oral administration of capsules containing 100 mg of purified gluten. Receives: Behavioral: Gluten (behaviour); Behavioral: Placebo (behaviour) |
| Purified gluten (500 mg) | Active comparator | Oral administration of capsules containing 500 mg of purified gluten. Receives: Behavioral: Gluten (behaviour); Behavioral: Placebo (behaviour) |
| Purified gluten (1000 mg) | Active comparator | Oral administration of capsules containing 1000 mg of purified gluten. Receives: Behavioral: Gluten (behaviour); Behavioral: Placebo (behaviour) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-response relationship between the amount of gluten intake and urinary excretion of GIP.
The primary objective of the study is to verify the usefulness of the quantitative GIP assay in urine as biomarker of adherence to the gluten-free diet in terms of dose-response relationship between the amount of ingested gluten and urinary excretion of GIP in a group of healthy volunteers.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Oct 2020
- Primary completion30 Nov 2020
- Study completion31 Dec 2020
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Politecnica delle Marche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Catassi, M.D., Università Politecnica delle Marche
- Investigators
- Carlo Catassi, MD, MPH, Study director, Univeristà Politecnica delle Marche, Ancona, ItalyElena Lionetti, MD, PHD, Principal investigator, Univeristà Politecnica delle Marche, Ancona, ItalySimona Gatti, MD, PHD, Study chair, Univeristà Politecnica delle Marche, Ancona, ItalyChiara Monachesi, PHD, Study chair, Univeristà Politecnica delle Marche, Ancona, ItalyAnil K Verma, PHD, Study chair, Univeristà Politecnica delle Marche, Ancona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477239
- Sponsor's protocol ID
- GRRES-2020-1551
- Status last verified
- Dec 2024
- First submitted
- 14 Jul 2020
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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 26608460Stefanolo JP, Talamo M, Dodds S, de la Paz Temprano M, Costa AF, Moreno ML, Pinto-Sanchez MI, Smecuol E, Vazquez H, Gonzalez A, Niveloni SI, Maurino E, Verdu EF, Bai JC. Real-World Gluten Exposure in Patients With Celiac Disease on Gluten-Free Diets, Determined From Gliadin Immunogenic Peptides in Urine and Fecal Samples. Clin Gastroenterol Hepatol. 2021 Mar;19(3):484-491.e1. doi: 10.1016/j.cgh.2020.03.038. Epub 2020 Mar 23.
PubMed 32217152Silvester JA, Comino I, Kelly CP, Sousa C, Duerksen DR; DOGGIE BAG Study Group. Most Patients With Celiac Disease on Gluten-Free Diets Consume Measurable Amounts of Gluten. Gastroenterology. 2020 Apr;158(5):1497-1499.e1. doi: 10.1053/j.gastro.2019.12.016. Epub 2019 Dec 19. No abstract available.
PubMed 31866245Verma AK, Gatti S, Galeazzi T, Monachesi C, Padella L, Baldo GD, Annibali R, Lionetti E, Catassi C. Gluten Contamination in Naturally or Labeled Gluten-Free Products Marketed in Italy. Nutrients. 2017 Feb 7;9(2):115. doi: 10.3390/nu9020115.
PubMed 28178205Catassi C, Fabiani E, Iacono G, D'Agate C, Francavilla R, Biagi F, Volta U, Accomando S, Picarelli A, De Vitis I, Pianelli G, Gesuita R, Carle F, Mandolesi A, Bearzi I, Fasano A. A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease. Am J Clin Nutr. 2007 Jan;85(1):160-6. doi: 10.1093/ajcn/85.1.160.
PubMed 17209192Monachesi C, Verma AK, Catassi GN, Franceschini E, Gatti S, Gesuita R, Lionetti E, Catassi C. Determination of Urinary Gluten Immunogenic Peptides to Assess Adherence to the Gluten-Free Diet: A Randomized, Double-Blind, Controlled Study. Clin Transl Gastroenterol. 2021 Oct 6;12(10):e00411. doi: 10.14309/ctg.0000000000000411.
PubMed 34613954
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Triple-blind, Placebo-controlled, Clinical Trial on the Diagnostic Performance of Gluten Immunogenic Peptides in the Evaluation of Gluten-free Diet Adherence: the GRRES Study.
- ClinicalTrials.gov ID
- NCT04477239
- Acronym / sponsor ID
- GRRES-2020-1551
- Conditions
- Celiac Disease
- Keywords
- Gluten-free diet, Gluten immunogenic peptides, Gluten contamination, Gluten, Urine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Università Politecnica delle MarcheUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Jul 2020 (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 purpose of the GRRES study is to assess the clinical usefulness of urinary gluten immunogenic peptides test as a marker of gluten-free diet adherence using the rapid immunochromatographic assay based on anti-gliadin 33-mer monoclonal antibodies.
Detailed description
A strict and permanent gluten free diet (GFD) is the only effective treatment resulting in full clinical, serological and histological remission, avoiding long-term complications in celiac disease (CD) patients. Gluten immunogenic peptides (GIP) are fragments of gluten proteins resistant to gastrointestinal digestion and detectable in urine after intestinal digestion, providing direct evidence of recent gluten ingestion. A significant variability in the amount of excreted urinary GIP has been reported in individuals administered with similar doses of gluten and, so far, inadequate information is available about the amount of excreted GIP in subjects ingesting traces or low amount of gluten. This is an important issue, as even a strict GFD could be contaminated by traces of gluten, e.g. in wheat starch and processed food. The aim of this study is to assess the clinical usefulness of urinary GIP as a marker of GFD adherence using a rapid immunochromatographic assay based on anti-gliadin 33-mer monoclonal antibodies. This is a prospective, randomized, triple-blind, placebo-controlled, clinical trial. In this study, healthy volunteers following a normal diet will be requested to be on strict GFD for 5 days. On day 4th, participants will be requested to collect a baseline urine sample and in case of a negative GIP test result they will be assigned to ingest a specific dose of purified gluten incorporated in a capsule (0 mg, 10 mg, 50 mg, 100 mg, 500 mg and 1000 mg, according to randomization). Participants will be requested to collect urine samples in a container and take a 5 mL aliquote for the GIP test at the 9th and 24th hour from the time of the administration of the dose. During the collection, volunteers will also be requested to record the volume of the excreted urine and to store the collected urine at 4°C. Urine tubes will be stored at -20°C until the quantitative evaluation of GIP. GIP test will be performed using the rapid immunochromatographic assay based on anti-gliadin 33-mer monoclonal antibodies iVYCHECK GIP Urine™ test (Biomedal, Spain) according to the manufacturer's instructions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Behavioral: Gluten (behaviour), Behavioral: Placebo (behaviour)Oral administration of one capsule of Placebo |
| Purified gluten (10 mg) | Active comparator | Behavioral: Gluten (behaviour), Behavioral: Placebo (behaviour)Oral administration of capsules containing 10 mg of purified gluten. |
| Purified gluten (50 mg) | Active comparator | Behavioral: Gluten (behaviour), Behavioral: Placebo (behaviour)Oral administration of capsules containing 50 mg of purified gluten. |
| Purified gluten (100 mg) | Active comparator | Behavioral: Gluten (behaviour), Behavioral: Placebo (behaviour)Oral administration of capsules containing 100 mg of purified gluten. |
| Purified gluten (500 mg) | Active comparator | Behavioral: Gluten (behaviour), Behavioral: Placebo (behaviour)Oral administration of capsules containing 500 mg of purified gluten. |
| Purified gluten (1000 mg) | Active comparator | Behavioral: Gluten (behaviour), Behavioral: Placebo (behaviour)Oral administration of capsules containing 1000 mg of purified gluten. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy volunteers
- 20-40 years old
- written informed consent
Key exclusion criteria (5 listed)
- type 1 diabetes
- chronic or acute inflammatory diseases of the gastrointestinal tract (CD, non-celiac gluten sensitivity, Crohn's disease, ulcerative colitis, food allergy, acute gastroenteritis ≤ 4 weeks prior to the study start)
- pregnancy or lactation
- chronic intake of medications and supplements
- refusal/withdrawal of written informed consent.
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 |
|---|---|---|
| Gluten (behaviour)Gluten is a protein normally present in the daily diet of healthy volunteers not suffering from gluten related disorders, in far greater quantities (10-20 g/day) than those used in this study (10 mg-1 g/day). | Behavioural | Placebo, Purified gluten (10 mg), Purified gluten (100 mg), Purified gluten (1000 mg), Purified gluten (50 mg), Purified gluten (500 mg) |
| Placebo (behaviour)Placebo is composed of pregelatinized maize starch Ph.Eur. 97.5%; magnesium stearate Ph.Eur. 1.5%; micronized silica Ph.Eur. 0.5%; Micronized talc Ph.Eur. 0.5% (NOT containing preservatives, colorings, or gluten). | Behavioural | Placebo, Purified gluten (10 mg), Purified gluten (100 mg), Purified gluten (1000 mg), Purified gluten (50 mg), Purified gluten (500 mg) |
Primary outcome
Dose-response relationship between the amount of gluten intake and urinary excretion of GIP.
Time frame: 3 months
The primary objective of the study is to verify the usefulness of the quantitative GIP assay in urine as biomarker of adherence to the gluten-free diet in terms of dose-response relationship between the amount of ingested gluten and urinary excretion of GIP in a group of healthy volunteers.
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 Dec 2024.
- 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 32217152Stefanolo JP, Talamo M, Dodds S, de la Paz Temprano M, Costa AF, Moreno ML, Pinto-Sanchez MI, Smecuol E, Vazquez H, Gonzalez A, Niveloni SI, Maurino E, Verdu EF, Bai JC. Real-World Gluten Exposure in Patients With Celiac Disease on Gluten-Free Diets, Determined From Gliadin Immunogenic Peptides in Urine and Fecal Samples. Clin Gastroenterol Hepatol. 2021 Mar;19(3):484-491.e1. doi: 10.1016/j.cgh.2020.03.038. Epub 2020 Mar 23.
- Background: PubMed 31866245Silvester JA, Comino I, Kelly CP, Sousa C, Duerksen DR; DOGGIE BAG Study Group. Most Patients With Celiac Disease on Gluten-Free Diets Consume Measurable Amounts of Gluten. Gastroenterology. 2020 Apr;158(5):1497-1499.e1. doi: 10.1053/j.gastro.2019.12.016. Epub 2019 Dec 19. No abstract available.
- Background: PubMed 28178205Verma AK, Gatti S, Galeazzi T, Monachesi C, Padella L, Baldo GD, Annibali R, Lionetti E, Catassi C. Gluten Contamination in Naturally or Labeled Gluten-Free Products Marketed in Italy. Nutrients. 2017 Feb 7;9(2):115. doi: 10.3390/nu9020115.
- Background: PubMed 17209192Catassi C, Fabiani E, Iacono G, D'Agate C, Francavilla R, Biagi F, Volta U, Accomando S, Picarelli A, De Vitis I, Pianelli G, Gesuita R, Carle F, Mandolesi A, Bearzi I, Fasano A. A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease. Am J Clin Nutr. 2007 Jan;85(1):160-6. doi: 10.1093/ajcn/85.1.160.
- Derived from this study: PubMed 34613954Monachesi C, Verma AK, Catassi GN, Franceschini E, Gatti S, Gesuita R, Lionetti E, Catassi C. Determination of Urinary Gluten Immunogenic Peptides to Assess Adherence to the Gluten-Free Diet: A Randomized, Double-Blind, Controlled Study. Clin Transl Gastroenterol. 2021 Oct 6;12(10):e00411. doi: 10.14309/ctg.0000000000000411.
- Individual participant dataSharing planned: Undecided
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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.
Carlo Catassi, MD, MPH study director
Univeristà Politecnica delle Marche, Ancona, Italy
Elena Lionetti, MD, PHD principal investigator
Univeristà Politecnica delle Marche, Ancona, Italy
Simona Gatti, MD, PHD study chair
Univeristà Politecnica delle Marche, Ancona, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten (behaviour) in people with Celiac Disease, run by Università Politecnica delle Marche 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 3 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 9 Dec 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 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. Some participants in this study may receive a placebo. 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?
Dose-response relationship between the amount of gluten intake and urinary excretion of GIP. (time frame: 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 NCT04477239, 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 9 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.