NCT05066191

Brief Summary

The primary aim of the study is to detect the presence of gluten immunogenic peptides (GIP) in urine samples from celiac patients on a gluten-free diet clinically responsive and non-responsive to dietary treatment and from suspected celiac patients already on a gluten-free diet.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

3 years

First QC Date

September 23, 2021

Last Update Submit

September 23, 2021

Conditions

Celiac Disease

Keywords

non celiac gluten sensitivitygluten reintroductionGIP

Outcome Measures

Primary Outcomes (1)

  • GIP

    GIP Immunogenic Peptide Assay in Urine

    3 weeks

Secondary Outcomes (1)

  • Gluten-free diet

    3 weeks

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be patients with celiac disease and suspected celiac disease (about 300)

You may qualify if:

  • Age: 18 to 65 years old
  • Gender: Males and Females
  • Patients: suffering from Celiac Disease and suspected, but already on a gluten-free diet

You may not qualify if:

  • Celiac patients less than 6 months after diagnosis
  • Celiac patients reporting intentional gluten ingestion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano

Milan, MI, 20122, Italy

RECRUITING

Related Publications (3)

  • Comino I, Real A, Vivas S, Siglez MA, Caminero A, Nistal E, Casqueiro J, Rodriguez-Herrera A, Cebolla A, Sousa C. Monitoring of gluten-free diet compliance in celiac patients by assessment of gliadin 33-mer equivalent epitopes in feces. Am J Clin Nutr. 2012 Mar;95(3):670-7. doi: 10.3945/ajcn.111.026708. Epub 2012 Jan 18.

    PMID: 22258271RESULT

  • Comino I, Fernandez-Banares F, Esteve M, Ortigosa L, Castillejo G, Fambuena B, Ribes-Koninckx C, Sierra C, Rodriguez-Herrera A, Salazar JC, Caunedo A, Marugan-Miguelsanz JM, Garrote JA, Vivas S, Lo Iacono O, Nunez A, Vaquero L, Vegas AM, Crespo L, Fernandez-Salazar L, Arranz E, Jimenez-Garcia VA, Antonio Montes-Cano M, Espin B, Galera A, Valverde J, Giron FJ, Bolonio M, Millan A, Cerezo FM, Guajardo C, Alberto JR, Rosinach M, Segura V, Leon F, Marinich J, Munoz-Suano A, Romero-Gomez M, Cebolla A, Sousa C. Fecal Gluten Peptides Reveal Limitations of Serological Tests and Food Questionnaires for Monitoring Gluten-Free Diet in Celiac Disease Patients. Am J Gastroenterol. 2016 Oct;111(10):1456-1465. doi: 10.1038/ajg.2016.439. Epub 2016 Sep 20.

    PMID: 27644734RESULT

  • 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: 26608460RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

urinary and fecal samples

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Luca Elli, PhD

    Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maurizio Vecchi, MD

CONTACT

0255033418maurizio.vecchi@policlinico.mi.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastroenterologist

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 4, 2021

Study Start

February 1, 2019

Primary Completion

February 1, 2022

Study Completion

March 31, 2022

Last Updated

October 4, 2021

Record last verified: 2021-09

Locations

IT(1)