Preventing Celiac Disease by Weaning With Mediterranean Diet

NCT06184906 | Not Yet Recruiting Phase 3

• 1 other identifier: PREVENTCELIAC
• Study Type: interventional
• Target: 3,200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Weaning Failure

Keywords

Infant Weaning; Mediterranean Diet; Celiac Disease

Outcome Measures

Primary Outcomes (2)

• Incidence of Celiac Disease

  Monitoring the incidence of Celiac Disease in the study population.

  3 to 6 years of age

• 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 Outcomes (2)

• Beneficial Microbiome

  5 to 6 years of age

• Bifidibacteriaceae in the feces

  5 years

Study Arms (2)

CONTROLS

PLACEBO COMPARATOR

Participants in the control arm will undergo a traditional weaning process. This involves primarily the use of industrial baby foods, with a gradual introduction of fresh foods. Legumes will be introduced at around 7-8 months, and fresh fish will be incorporated into the diet after one year of age.

Dietary Supplement: Weaning by Mediterranean Diet

Treated

EXPERIMENTAL

Participants in the experimental arm will follow a Mediterranean Diet (MD) weaning schema. This approach includes exclusively fresh foods that are part of the traditional MD, modified to suit infants. Key elements of this diet include: * Seasonal fruit and vegetables, such as broccoli and cauliflower, served as purees from the beginning of weaning. * A variety of fresh blue fish (e.g., anchovies, mackerel, flag fish, cod, sole) introduced at 7 months, seasoned with garlic and cherry tomatoes. * Use of spices and herbs like thyme, marjoram, rosemary, parsley, garlic, and onion to flavor meals. * Exclusion of salt; meals are instead enhanced with 2 g of Parmesan cheese for taste. * Avoidance of sweets.

Dietary Supplement: Weaning by Mediterranean Diet

Interventions

Weaning by Mediterranean Diet DIETARY_SUPPLEMENT

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

CONTROLS; Treated

Eligibility Criteria

• Age: 1 Month - 10 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- Healthy newborns with a birth weight greater than 2000 grams.
• Residence in Municipality 8, Piscinola-Scampia.

You may not qualify if:

• \- Newborns suffering from severe prematurity.
• Newborns with congenital malformations.
• Newborns afflicted by severe diseases.

Sponsors & Collaborators

• University of Naples: lead

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

LUIGI GRECO

CONTACT

3341587925; ydongre@unina.it

RENATA AURICCHIO

CONTACT

+393392507648; rRenata Auricchio <r.auricchio@unina.it>

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data manager are blind to treatment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 29, 2023
• Study Start: June 15, 2024
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share