Weaning FailurePhase 3PEMEDNCT06184906
Preventing Celiac Disease by Weaning With Mediterranean Diet
A Phase 3 study testing Weaning by Mediterranean Diet in people with Weaning Failure, run by University of Naples.
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. Read more about this study
- Who is it for?
- Ages 1 month to 10 months
- Conditions the study is for
- Weaning Failure
- What is being tested?
- Weaning by Mediterranean Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,200 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to 31 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 10 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- - Healthy newborns with a birth weight greater than 2000 grams.
- Residence in Municipality 8, Piscinola-Scampia.
Who cannot join
- - Newborns suffering from severe prematurity.
- Newborns with congenital malformations.
- Newborns afflicted by severe diseases.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Weaning Failure
- Being tested
- Weaning by Mediterranean Diet
- Keywords
- Infant Weaning, Mediterranean Diet, Celiac Disease
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weaning by Mediterranean DietDietary supplement
Introduce solid foods typical of the Mediterranean Diet at weaning of infants
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Weaning by Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Celiac Disease
Monitoring the incidence of Celiac Disease in the study population.
Measured: 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.
Measured: 4 to 6 years
Secondary outcomes (2)
Beneficial Microbiome
Evaluating the composition of the microbiome for beneficial characteristics.
Measured: 5 to 6 years of age
Bifidibacteriaceae in the feces
Measuring the variation of Bifidobacteria in feces.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start15 Jun 2024 (estimated)
- Primary completion30 Sep 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Greco, University of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184906
- Sponsor's protocol ID
- PREVENTCELIAC
- Acronym
- PEMED
- Status last verified
- May 2024
- First submitted
- 23 Nov 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Celiac Disease by Weaning With Mediterranean Diet
- ClinicalTrials.gov ID
- NCT06184906
- Acronym / sponsor ID
- PEMED / PREVENTCELIAC
- Conditions
- Weaning Failure
- Keywords
- Infant Weaning, Mediterranean Diet, Celiac Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- University of NaplesUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CONTROLS | Placebo comparator | Dietary Supplement: Weaning by Mediterranean DietParticipants 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. |
| Treated | Experimental | Dietary Supplement: Weaning by Mediterranean DietParticipants 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. |
Who may qualify
- Ages
- 1 month to 10 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- - Healthy newborns with a birth weight greater than 2000 grams.
- Residence in Municipality 8, Piscinola-Scampia.
Key exclusion criteria (3 listed)
- - Newborns suffering from severe prematurity.
- Newborns with congenital malformations.
- Newborns afflicted by severe diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weaning by Mediterranean DietIntroduce solid foods typical of the Mediterranean Diet at weaning of infants | Dietary supplement | CONTROLS, Treated |
Primary outcome
Incidence of Celiac Disease
Time frame: 3 to 6 years of age
Monitoring the incidence of Celiac Disease in the study population.
Children growth
Time frame: 4 to 6 years
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.
2 secondary outcomes
Beneficial Microbiome
Time frame: 5 to 6 years of age
Bifidibacteriaceae in the feces
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Weaning by Mediterranean Diet in people with Weaning Failure, run by University of Naples.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LUIGI GRECO (3341587925, ydongre@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Celiac Disease (time frame: 3 to 6 years of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.