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Diagnostic Performance of Urinary Gluten Immunogenic Peptides in Monitoring the Adherence to Gluten-free Diet.

NCT ID: NCT04477239

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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

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Celiac Disease

Keywords

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Gluten-free diet Gluten immunogenic peptides Gluten contamination Gluten Urine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Randomization will be performed using a random sequence generator to conceal the sequence from the rest of the researchers and to ensure that only the investigator who will manipulate the gluten doses will know the allocation pertaining to each individual. This investigator will not carry out any assessment or any other intervention during the trial period. Until study completion, the enrolled subjects, the clinicians and the person who will perform the statistical analysis will be blinded to the group assigned.

Study Groups

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Placebo

Oral administration of one capsule of Placebo

Group Type PLACEBO_COMPARATOR

Gluten (behaviour)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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).

Purified gluten (10 mg)

Oral administration of capsules containing 10 mg of purified gluten.

Group Type ACTIVE_COMPARATOR

Gluten (behaviour)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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).

Purified gluten (50 mg)

Oral administration of capsules containing 50 mg of purified gluten.

Group Type ACTIVE_COMPARATOR

Gluten (behaviour)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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).

Purified gluten (100 mg)

Oral administration of capsules containing 100 mg of purified gluten.

Group Type ACTIVE_COMPARATOR

Gluten (behaviour)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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).

Purified gluten (500 mg)

Oral administration of capsules containing 500 mg of purified gluten.

Group Type ACTIVE_COMPARATOR

Gluten (behaviour)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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).

Purified gluten (1000 mg)

Oral administration of capsules containing 1000 mg of purified gluten.

Group Type ACTIVE_COMPARATOR

Gluten (behaviour)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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).

Interventions

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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).

Intervention Type BEHAVIORAL

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Università Politecnica delle Marche

OTHER

Sponsor Role lead

Responsible Party

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Carlo Catassi, M.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlo Catassi, MD, MPH

Role: STUDY_DIRECTOR

Univeristà Politecnica delle Marche, Ancona, Italy

Elena Lionetti, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Univeristà Politecnica delle Marche, Ancona, Italy

Simona Gatti, MD, PHD

Role: STUDY_CHAIR

Univeristà Politecnica delle Marche, Ancona, Italy

Chiara Monachesi, PHD

Role: STUDY_CHAIR

Univeristà Politecnica delle Marche, Ancona, Italy

Anil K Verma, PHD

Role: STUDY_CHAIR

Univeristà Politecnica delle Marche, Ancona, Italy

Locations

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University Department of Pediatrics

Ancona, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 26608460 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32217152 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31866245 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28178205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17209192 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34613954 (View on PubMed)

Other Identifiers

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GRRES-2020-1551

Identifier Type: -

Identifier Source: org_study_id