Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06364735
Other study ID # Entità e variabili
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04440501 - Virtual Reality to Teach, Improve Outcomes, and Engage (VIRTUE): Virtual Reality to Improve Gluten-Free Diet Knowledge in Pediatric Celiac Disease N/A
Enrolling by invitation NCT06179121 - "Adding DNA-test for Screening of HLA-DQ2 and DQ8 to Improve Early Diagnosis of Celiac Disease"
Recruiting NCT06324539 - Validation of a New Innovative Method for Specific Marker Detection in Celiac Disease
Completed NCT06359613 - Efficacy Assessment of Gluten Free Cupcakes N/A
Active, not recruiting NCT05548166 - Development of CELIAC-Q KIDS: A Patient-Reported Outcome Measure for Pediatric Celiac Disease
Recruiting NCT04014660 - Prevention av Autoimmunitet Med Laktobaciller N/A
Not yet recruiting NCT04019223 - Anti-Tissue Transglutaminase IgA Antibodies
Completed NCT03966625 - Serological Identification of Celiac Disease in Kids
Not yet recruiting NCT03244254 - Intestinal Fatty Acid-binding Protein (I-FABP) Levels in Pediatric Celiac Patients N/A
Recruiting NCT05132725 - Carbohydrate Counting and DASH Intervention Among Children With Diabetes and Celiac Disease. N/A
Enrolling by invitation NCT05084937 - Celiac Disease in Childhood-Adulthood Transition N/A
Active, not recruiting NCT04593888 - Gluten Reduction and Risk of Celiac Disease N/A
Recruiting NCT06007898 - Supporting Children and Young People to Live Well With Coeliac Disease N/A
Completed NCT04272983 - Population Study of the Prevalence of Celiac Disease and Other Gluten-dependent Disorders in Children and Adolescents
Not yet recruiting NCT06149507 - Effect of Acetaminophen Versus Ibuprofen in Treating Recurrent Apthous Ulcers in Pediatric Celiac Disease Phase 4
Completed NCT04240340 - Experiences of Disclosure in Adolescents With Coeliac Disease
Completed NCT03176095 - Celiac Disease Prevention With Probiotics N/A
Active, not recruiting NCT06038344 - Influence of a Gluten Free Food Guide on Diet Quality and Adherence to the GFD in Youth With Celiac Disease N/A
Completed NCT04533776 - Support for Adolescents With Celiac Disease N/A
Completed NCT03663309 - Assessment of Adherence to Gluten Free Diet in Children and Adolescents by Detection of Gluten in Faecal Samples.