NCT06364735 Entities and Variables Related to Catch-up Growth
| NCT ID | NCT06364735 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ASST Fatebenefratelli Sacco |
| Condition | Celiac Disease in Children |
| Study Type | OBSERVATIONAL |
| Enrollment | 900 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2024-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 900 participants in total. It began in 2024-07-01 with a primary completion date of 2024-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06364735 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Celiac Disease in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06364735 currently recruiting?
Yes, NCT06364735 is actively recruiting participants. Contact the research team at elena.groppali@asst-fbf-sacco.it for enrollment information.
Where is the NCT06364735 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06364735 clinical trial?
NCT06364735 is sponsored by ASST Fatebenefratelli Sacco. The trial plans to enroll 900 participants.