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Preventing Celiac Disease by Weaning With Mediterranean Diet

NCT06184906 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3200

Last updated 2024-05-08

No results posted yet for this study

Summary

Background: The introduction of solid foods in alignment with the Mediterranean Diet (MD) post-exclusive milk feeding has been demonstrated to cultivate a lasting affinity for healthy eating during infancy and childhood. Despite this, access to healthy diets remains a challenge for numerous children, particularly in underserved areas. The clinical trial under discussion is set in Scampia, a municipality in Naples, Italy, known for its dense population and socio-economic challenges. This trial, utilizing the Family Pediatrician (FP) system, aims to promote MD nutrition among children in Scampia to potentially prevent or reduce chronic childhood diseases.

Study Design: In this pragmatic trial, FPs are utilized as the unit for randomization to administer the intervention. The intervention group will be introduced to an intensified MD-based diet from weaning, incorporating adult-type MD foods, while the control group will follow standard regional dietary guidelines. Dietary adherence and health outcomes are to be periodically monitored, and genetic and microbiome analyses will be conducted using collected saliva and stool samples. Incorporating a Bayesian group sequential design, this trial is structured to conduct interim analyses for efficacy, aligning with local healthcare systems for optimal resource allocation.

Conclusion: The study is poised to be methodologically innovative and socially impactful, utilizing existing healthcare frameworks to enhance childhood nutrition in challenging environments. Outcomes from this trial are expected to provide valuable insights into the effects of MD-based nutrition on child health and potentially serve as a model for promoting healthier diets in urban suburbs globally.

Conditions

  • Weaning Failure

Interventions

DIETARY_SUPPLEMENT

Weaning by Mediterranean Diet

Introduce solid foods typical of the Mediterranean Diet at weaning of infants

Sponsors & Collaborators

  • University of Naples

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
10 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-15
Primary Completion
2030-09-30
Completion
2030-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06184906 on ClinicalTrials.gov