NCT05119868 Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring
| NCT ID | NCT05119868 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federico II University |
| Condition | Allergies |
| Study Type | INTERVENTIONAL |
| Enrollment | 276 participants |
| Start Date | 2021-11-02 |
| Primary Completion | 2025-01-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 276 participants in total. It began in 2021-11-02 with a primary completion date of 2025-01-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Allergy prevalence is increasing steadily with some describing as the "epidemic of the twenty-first century". Maternal diet during pregnancy has been linked to offspring allergy risk, so it represents a potential target for allergy prevention. The Mediterranean Diet (MD) is considered one of the healthiest dietary models which exerts regulatory effects on immune system, due to the synergistic and interactive combinations of nutrients. We aim to study the effects of MD in pregnancy on the onset of allergic diseases at 2 years of age in the offspring.
Eligibility 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.
Contact & Investigator
Roberto Berni Canani
PRINCIPAL INVESTIGATOR
Department of Traslational Medical Science at University of Naples Federico II
Frequently Asked Questions
Who can join the NCT05119868 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 35 Years, studying Allergies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05119868 currently recruiting?
Yes, NCT05119868 is actively recruiting participants. Contact the research team at berni@unina.it for enrollment information.
Where is the NCT05119868 trial being conducted?
This trial is being conducted at Naples, Italy, Naples, Italy.
Who is sponsoring the NCT05119868 clinical trial?
NCT05119868 is sponsored by Federico II University. The principal investigator is Roberto Berni Canani at Department of Traslational Medical Science at University of Naples Federico II. The trial plans to enroll 276 participants.