Entities and Variables Related to Catch-up Growth

NCT ID: NCT06364735

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-01-01

Brief Summary

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A retrospective monocentric observational no-profit study with the aim of evaluating the entity and potential variables influencing the catch-up growth of childhood gluten-free diet patients with celiac disease during a 10-year follow-up. The only extrapolation of the data collected in anonymized form from the medical records of patients who match the necessary study criteria will be planned in order to achieve this aim. A 900-patient sample size will be planned.

Detailed Description

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Conditions

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Celiac Disease in Children

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* celiac disease diagnosis established at the V. Buzzi Children\'s Hospital in Milan between January 2010 and December 2020, excluding the extremes, in accordance with the ESPGHAN 2012 or 2020 recommendations.

Exclusion Criteria

* patients with unclear or non-specific duodenal histological alterations (e.g., atrophy with unavailable or negative specific antibodies for celiac disease);
* patients with additional chronic illnesses;
* absence of the data required for the study;
* patients with IgA deficiency, defined as IgA \<20 mg/dl in children \<3 years old or with levels that are below normal for their age.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ASST Fatebenefratelli Sacco

OTHER

Sponsor Role lead

Responsible Party

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Elena Groppali

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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ASST Fatebenefratelli Sacco

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Elena Groppali, MD

Role: CONTACT

00390263631

Elena Groppali, MD

Role: CONTACT

00390263635331

Facility Contacts

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Elena MD Groppali

Role: primary

Elena MD Groppali

Role: backup

Other Identifiers

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Entità e variabili

Identifier Type: -

Identifier Source: org_study_id

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