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

NCT04477239 | Completed DMC

• 1 other identifier: GRRES-2020-1551
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease

Keywords

Gluten-free diet; Gluten immunogenic peptides; Gluten contamination; Gluten; Urine

Outcome Measures

Primary Outcomes (1)

• Dose-response relationship between the amount of gluten intake and urinary excretion of GIP.

  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

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Oral administration of one capsule of Placebo

Behavioral: Gluten (behaviour); Behavioral: Placebo (behaviour)

Purified gluten (10 mg)

ACTIVE COMPARATOR

Oral administration of capsules containing 10 mg of purified gluten.

Behavioral: Gluten (behaviour); Behavioral: Placebo (behaviour)

Purified gluten (50 mg)

ACTIVE COMPARATOR

Oral administration of capsules containing 50 mg of purified gluten.

Behavioral: Gluten (behaviour); Behavioral: Placebo (behaviour)

Purified gluten (100 mg)

ACTIVE COMPARATOR

Oral administration of capsules containing 100 mg of purified gluten.

Behavioral: Gluten (behaviour); Behavioral: Placebo (behaviour)

Purified gluten (500 mg)

ACTIVE COMPARATOR

Oral administration of capsules containing 500 mg of purified gluten.

Behavioral: Gluten (behaviour); Behavioral: Placebo (behaviour)

Purified gluten (1000 mg)

ACTIVE COMPARATOR

Oral administration of capsules containing 1000 mg of purified gluten.

Behavioral: Gluten (behaviour); Behavioral: Placebo (behaviour)

Interventions

Gluten (behaviour) 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; Purified gluten (10 mg); Purified gluten (100 mg); Purified gluten (1000 mg); Purified gluten (50 mg); Purified gluten (500 mg)

Placebo (behaviour) 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).

Placebo; Purified gluten (10 mg); Purified gluten (100 mg); Purified gluten (1000 mg); Purified gluten (50 mg); Purified gluten (500 mg)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy volunteers
• years old
• written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università Politecnica delle Marche: lead

Study Sites (1)

University Department of Pediatrics

Ancona, 60123, Italy

Location

Related Publications (6)

• 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.

  PMID: 26608460 BACKGROUND

• 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.

  PMID: 32217152 BACKGROUND

• 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.

  PMID: 31866245 BACKGROUND

• 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.

  PMID: 28178205 BACKGROUND

• 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.

  PMID: 17209192 BACKGROUND

• 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.

  PMID: 34613954 DERIVED

MeSH Terms

Conditions

Celiac Disease

Interventions

Glutens

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Prolamins; Grain Proteins; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Seed Storage Proteins

Study Officials

• Carlo Catassi, MD, MPH

  Univeristà Politecnica delle Marche, Ancona, Italy

  STUDY DIRECTOR

• Elena Lionetti, MD, PHD

  Univeristà Politecnica delle Marche, Ancona, Italy

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 20, 2020
• Study Start: October 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2020
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

IT (1)