Entities and Variables Related to Catch-up Growth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Celiac Disease in Children. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Entities and Variables Related to Catch-up Growth in Pediatric Patients With Celiac Disease (CD) on a Gluten-free Diet (GFD)
Overview
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.
Primary outcome measures
- Measure the catch-up growth degree. [Time frame: 6 and 24 month]
Secondary outcome measures (1)
- Calculate the degree of catch-up growth [Time frame: 6 and 24 month]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Italy · 1 center
- ASST Fatebenefratelli Sacco — Milan
Identifiers
NCT: NCT06364735 · Entità e variabili