Preventing Celiac Disease by Weaning With Mediterranean Diet

Weaning Failure Clinical Trial

— PEMED  

Official title:

Preventing Celiac Disease by Weaning With Mediterranean Diet

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06184906
• Other study ID #: PREVENTCELIAC
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 15, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: May 2024
• Source: University of Naples
• Contact: LUIGI GRECO
• Phone: 3341587925
• Email: ydongre[@]unina.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Detailed Description:

The relationship between systemic chronic inflammation and various chronic diseases, such as obesity, diabetes, cancer, autoimmune, and inflammatory bowel diseases, is well-recognized. Given the economic impact of these diseases on healthcare systems, a comprehensive strategy for risk prevention is imperative. Diet and intestinal dysbiosis are identified as major triggers for systemic chronic inflammation. The MD, characterized by its anti-inflammatory qualities, has also been noted for its positive effects on gut microbiota. The timing of introducing the MD is critical for fostering a healthy microbiota, with early exposure being advantageous. Furthermore, early dietary experiences are crucial in shaping future food preferences. Evidence suggests that responsive feeding practices, such as baby-led weaning, may offer protection against obesity. While the early introduction of the MD in children remains under-researched, its potential protective role against diseases like celiac and inflammatory bowel diseases has been suggested. The PEMED trial, designed to promote MD nutrition among children in Scampia, represents a groundbreaking approach, utilizing a Bayesian cluster randomized clinical trial and the Italian family pediatrician system.

This study is unique in its exploration of introducing natural MD foods during infancy and assessing their impact on the establishment of lasting dietary preferences. It leverages the healthcare infrastructure of the Piscinola-Scampia district in Naples for a population-based Pragmatic Clinical Trial, exceeding traditional research design norms. The study is focused on assessing the impact of the MD on the incidence of diseases, employing a Bayesian adaptive sequential approach to allow for ongoing data analysis and adjustments. The PEMED trial's novel approach, combining the early introduction of the MD, population-based surveillance, and an advanced statistical methodology, is poised to set new benchmarks in pediatric research concerning diet and disease prevention.

The trial's objectives include evaluating the impact of the MD on the incidence of pediatric diseases, assessing the development of a 'protective' fecal microbiome, and analyzing the persistence of MD dietary choices in children up to the age of 5 years.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3200
• Est. completion date: December 31, 2030
• Est. primary completion date: September 30, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 10 Months

Eligibility

Inclusion Criteria:

• - Healthy newborns with a birth weight greater than 2000 grams.

• Residence in Municipality 8, Piscinola-Scampia.

Exclusion Criteria:

• - Newborns suffering from severe prematurity.

• Newborns with congenital malformations.

• Newborns afflicted by severe diseases.

Related Conditions & MeSH terms

• Celiac Disease
• Weaning Failure

Intervention

Dietary Supplement:
• Weaning by Mediterranean Diet
Introduce solid foods typical of the Mediterranean Diet at weaning of infants

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Naples

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Celiac Disease	Monitoring the incidence of Celiac Disease in the study population.	3 to 6 years of age
Primary	Children growth	Calculating the Body Mass Index (BMI kg/m^2) as a measure of growth, assessing if children's BMI falls within the normal range for their age and sex.	4 to 6 years
Secondary	Beneficial Microbiome	Evaluating the composition of the microbiome for beneficial characteristics.	5 to 6 years of age
Secondary	Bifidibacteriaceae in the feces	Measuring the variation of Bifidobacteria in feces.	5 years