Clinical trial NCT06184906: Preventing Celiac Disease by Weaning With Mediterranean Diet
Official title: Preventing Celiac Disease by Weaning With Mediterranean Diet
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Weaning Failure
Keywords: Infant Weaning
Mediterranean Diet
Celiac Disease
Lead sponsor: University of Naples
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 3200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: FP will be randomly assigned in a parallel 1:1 fashion to one of two intervention groups. A block randomization procedure will be considered for the allocation of FP to the intervention. To ensure unbiased allocation, this sequence will be concealed from investigators. Investigative sites will access the randomization information of enrolled participants through a dedicated online system via the RedCap interface10. In line with ethical considerations, enrolled participants and investigators will not be blinded to the study treatments, as the nature of the dietary intervention does not permit blinding. Therefore, unblinding will not be applicable in this trial. As part of the consent process, participants' permission will be sought to use their data even if they choose to withdraw from the trial. Additionally, participants will be asked for consent to share relevant data with researchers from participating universities or regulatory authorities, where relevant.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Celiac Disease
timeFrame: 3 to 6 years of age
measure: Children growth
timeFrame: 4 to 6 years
Secondary outcomes:
measure: Beneficial Microbiome
timeFrame: 5 to 6 years of age
measure: Bifidibacteriaceae in the feces
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
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