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

December 4, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Italy
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Oral administration of one capsule of Placebo
Behavioral: 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).
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).
Active Comparator: Purified gluten (10 mg)
Oral administration of capsules containing 10 mg of purified gluten.
Behavioral: 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).
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).
Active Comparator: Purified gluten (50 mg)
Oral administration of capsules containing 50 mg of purified gluten.
Behavioral: 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).
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).
Active Comparator: Purified gluten (100 mg)
Oral administration of capsules containing 100 mg of purified gluten.
Behavioral: 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).
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).
Active Comparator: Purified gluten (500 mg)
Oral administration of capsules containing 500 mg of purified gluten.
Behavioral: 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).
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).
Active Comparator: Purified gluten (1000 mg)
Oral administration of capsules containing 1000 mg of purified gluten.
Behavioral: 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).
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Università Politecnica delle Marche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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