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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04477239
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Carlo Catassi, M.D., Università Politecnica delle Marche

Brief 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.

Condition or disease Intervention/treatment Phase
Celiac Disease Behavioral: Gluten (behaviour) Behavioral: Placebo (behaviour) Not Applicable

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, crossover 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Health Services Research
Official Title: A Randomized, Triple-blind, Placebo-controlled, Crossover Clinical Trial on the Diagnostic Performance of Gluten Immunogenic Peptides in the Evaluation of Gluten-free Diet Adherence: the GRRES Study.
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04477239


Contacts
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Contact: Carlo Catassi, MD, MPH +39 071 5962364 c.catassi@univpm.it
Contact: Elena Lionetti, MD, PHD +39 071 596 2372 m.e.lionetti@univpm.it

Locations
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Italy
University Department of Pediatrics Recruiting
Ancona, Italy, 60123
Principal Investigator: Carlo Catassi, M.D.         
Sponsors and Collaborators
Università Politecnica delle Marche
Investigators
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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:

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Responsible Party: Carlo Catassi, M.D., Professor, Università Politecnica delle Marche
ClinicalTrials.gov Identifier: NCT04477239    
Other Study ID Numbers: GRRES-2020-1551
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carlo Catassi, M.D., Università Politecnica delle Marche:
Gluten-free diet
Gluten immunogenic peptides
Gluten contamination
Gluten
Urine
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases