Impact of the Mediterranean Diet during Pregnancy on Allergies in Children
Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring: a Multi-center Randomised-controlled Trial (the PREMEDI Project)
This study is testing if pregnant women who follow a Mediterranean Diet can help reduce the chances of their children developing allergies by the time they turn two.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 276 (estimated) |
| Ages | 20 Years to 35 Years |
| Sex | Female |
| Sponsor | Federico II University Academic / other |
| Locations | 2 sites (Naples and 1 other locations) |
| Trial ID | NCT05119868 on ClinicalTrials.gov |
What this trial studies
This study investigates how following a Mediterranean Diet during pregnancy may influence the development of allergies in children by the age of two. It focuses on healthy women aged 20-35 who are in their first trimester and at risk of having an atopic baby. The intervention involves a nutritional regimen based on the Mediterranean Diet, which is known for its beneficial effects on the immune system. The goal is to determine if this dietary approach can reduce the incidence of allergic diseases in offspring.
Who should consider this trial
Good fit: Ideal candidates are healthy pregnant women aged 20-35 who are in their first trimester and have a baby at risk for atopy.
Not a fit: Patients with pre-existing health conditions such as infections, malignancies, or autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to dietary recommendations that help prevent allergies in children.
How similar studies have performed: While the Mediterranean Diet is well-regarded for its health benefits, this specific approach to allergy prevention during pregnancy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- healthy women (aged 20-35 years), at first trimester of pregnancy, of at risk for atopy baby Exclusion Criteria: * concomitant presence of infections; * concomitant presence of malignancies; * concomitant presence of major gastrointestinal malformations; * concomitant presence of immunodeficiencies; * concomitant presence of autoimmune diseases; * concomitant presence of chronic inflammatory bowel diseases; * concomitant presence of functional gastrointestinal disorders; * concomitant presence of celiac disease; * history of abdominal surgery with gastrointestinal resection; * concomitant presence of neuropsychiatric disorders; * concomitant presence of central nervous system disorders; * vegan diet; * twin pregnancy; * concomitant presence of genetic disorders; * concomitant presence of metabolic disorders.
Where this trial is running
Naples and 1 other locations
- Department of Traslational Medical Science - University of Naples Federico II — Naples, Italy (Recruiting)
- Department of Traslational Medical Science — Naples, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Roberto Berni Canani — Department of Traslational Medical Science at University of Naples Federico II
- Study coordinator: Roberto Berni Canani
- Email: berni@unina.it
- Phone: 0817462680
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.