- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04477239
Diagnostic Performance of Urinary Gluten Immunogenic Peptides in Monitoring the Adherence to Gluten-free Diet.
March 29, 2021 updated by: Carlo Catassi, M.D., Università Politecnica delle Marche
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ancona, Italy, 60123
- University Department of Pediatrics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy volunteers
- 20-40 years old
- written informed consent
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Oral administration of one capsule of Placebo
|
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 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).
|
Active Comparator: Purified gluten (10 mg)
Oral administration of capsules containing 10 mg of purified gluten.
|
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 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).
|
Active Comparator: Purified gluten (50 mg)
Oral administration of capsules containing 50 mg of purified gluten.
|
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 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).
|
Active Comparator: Purified gluten (100 mg)
Oral administration of capsules containing 100 mg of purified gluten.
|
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 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).
|
Active Comparator: Purified gluten (500 mg)
Oral administration of capsules containing 500 mg of purified gluten.
|
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 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).
|
Active Comparator: Purified gluten (1000 mg)
Oral administration of capsules containing 1000 mg of purified gluten.
|
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 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Carlo Catassi, MD, MPH, Univeristà Politecnica delle Marche, Ancona, Italy
- Principal Investigator: Elena Lionetti, MD, PHD, Univeristà Politecnica delle Marche, Ancona, Italy
- Study Chair: Simona Gatti, MD, PHD, Univeristà Politecnica delle Marche, Ancona, Italy
- Study Chair: Chiara Monachesi, PHD, Univeristà Politecnica delle Marche, Ancona, Italy
- Study Chair: Anil K Verma, PHD, Univeristà Politecnica delle Marche, Ancona, Italy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Stefanolo 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.
- Silvester 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.
- Verma 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.
- Catassi 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.
- Monachesi 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Actual)
November 30, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
July 14, 2020
First Submitted That Met QC Criteria
July 14, 2020
First Posted (Actual)
July 20, 2020
Study Record Updates
Last Update Posted (Actual)
April 1, 2021
Last Update Submitted That Met QC Criteria
March 29, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GRRES-2020-1551
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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