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

NCT04477239 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-12-09

No results posted yet for this study

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • Università Politecnica delle Marche

    lead OTHER

Principal Investigators

  • Carlo Catassi, MD, MPH · Univeristà Politecnica delle Marche, Ancona, Italy

  • Elena Lionetti, MD, PHD · Univeristà Politecnica delle Marche, Ancona, Italy

  • Simona Gatti, MD, PHD · Univeristà Politecnica delle Marche, Ancona, Italy

  • Chiara Monachesi, PHD · Univeristà Politecnica delle Marche, Ancona, Italy

  • Anil K Verma, PHD · Univeristà Politecnica delle Marche, Ancona, Italy

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2020-11-30
Completion
2020-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04477239 on ClinicalTrials.gov