Entities and Variables Related to Catch-up Growth

Celiac Disease in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06364735
• Other study ID #: Entità e variabili
• Status: Recruiting
• Start date: May 1, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2024
• Source: ASST Fatebenefratelli Sacco
• Contact: Elena Groppali, MD
• Phone: 00390263631
• Email: elena.groppali[@]asst-fbf-sacco.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Celiac Disease
• Celiac Disease in Children

Locations

Country	Name	City	State
Italy	ASST Fatebenefratelli Sacco	Milan

Sponsors (1)

Lead Sponsor	Collaborator
ASST Fatebenefratelli Sacco

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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