Entities and Variables Related to Catch-up Growth

Entities and Variables Related to Catch-up Growth in Pediatric Patients With Celiac Disease (CD) on a Gluten-free Diet (GFD)

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.

Study Overview

• Status: Recruiting
• Conditions: Celiac Disease in Children

• Study Type: Observational
• Enrollment (Estimated): 900

Contacts and Locations

• Study Contact: Name: Elena Groppali, MD; Phone Number: 00390263631; Email: elena.groppali@asst-fbf-sacco.it
• Study Contact Backup: Name: Elena Groppali, MD; Phone Number: 00390263635331; Email: elena.groppali@asst-fbf-sacco.it

Study Locations

• Italy
  • Milan, Italy, 2015
    • Recruiting
    • Asst Fatebenefratelli Sacco
    • Contact: Elena MD Groppali; Email: elena.groppali@asst-fbf-sacco.it
    • Contact: Elena MD Groppali
    • Principal Investigator: Elena MD Groppali

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Childhood celiac disease patients on a gluten-free diet

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the catch-up growth degree.	Changes in the auxological weight variable in pediatric patients with celiac disease were measured 6 months and 24 months after they started a gluten-free diet. The change was expressed as an average daily weight increase and compared with the average increase expected for sex and age in a healthy population extrapolated from validated curves (Cacciari).	6 and 24 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculate the degree of catch-up growth	Variation in the auxological variable of height in pediatric patients with celiac disease, measured as variation in the standard deviation of this variable compared to reference values for age and sex extrapolated from validated curves (Cacciari curves), at six and twenty-four months after the start of the gluten-free diet.	6 and 24 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory objectives 1	Identify the correlation between the degree of catch-up growth and the persistence of the symptoms, MC-related antibody positivity and the level of diet adherence at the 6- and 24-month follow-up	6 and 24 month
Exploratory objectives 2	Define the degree of celiac disease's clinical, endoscopic, histological, and serological severity at the time the sample was diagnosed, and then correlate it to the degree of catch-up growth that occurred 6 and 24 months after the gluten-free diet was started	6 and 24 month

Collaborators and Investigators

• Sponsor: ASST Fatebenefratelli Sacco

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: Entità e variabili

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No