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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05119868
Other study ID # 283/21
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 2, 2021
Est. completion date January 10, 2026

Study information

Verified date April 2023
Source Federico II University
Contact Roberto Berni Canani
Phone 0817462680
Email berni@unina.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 276
Est. completion date January 10, 2026
Est. primary completion date January 10, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 35 Years
Eligibility 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.

Study Design


Intervention

Other:
Nutritional intervention based on Mediterranean Diet
A personalized nutritional counseling and a tailored diet, according to Mediterranean dietary pattern, designed on the pre-pregnancy weight, height and trimester of pregnancy provided by certified dietitians.

Locations

Country Name City State
Italy Department of Traslational Medical Science Naples
Italy Department of Traslational Medical Science - University of Naples Federico II Naples

Sponsors (1)

Lead Sponsor Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of allergic disorders at 24 months of age in the offspring The evaluation of the effect of Mediterranean Diet during pregnancy on the occurrence of allergic disorders at 24 months of age in the offspring 24 months from birth
Secondary Maternal weight gain The evaluation of the effect of Mediterranean Diet during pregnancy on maternal weight gain From enrollment until delivery
Secondary Pregnancy complications occurrence The evaluation of the effect of Mediterranean Diet during pregnancy on pregnancy complications occurrence From enrollment until delivery
Secondary Perinatal complications occurrence The evaluation of the effect of Mediterranean Diet during pregnancy on perinatal complications occurrence Delivery
Secondary Neonatal birth weight The evaluation of the effect of Mediterranean Diet during pregnancy on neonatal growth indices Delivery
Secondary Body growth in the offspring The evaluation of the effect of Mediterranean Diet during pregnancy on body growth in the offspring During the 24 months of life
Secondary Occurrence of any other chronic disorders in the first 2 years of age in the offspring The evaluation of the effect of Mediterranean Diet during pregnancy on the occurrence of any other chronic disorders in the first 2 years of age in the offspring During the 24 months of life
Secondary Mother's gut microbiome metagenomic features The evaluation of the effect of Mediterranean Diet during pregnancy on the mother's gut microbiome metagenomic features From enrollment until delivery
Secondary Mother's gut microbiome metabolomic features The evaluation of the effect of Mediterranean Diet during pregnancy on the mother's gut microbiome metabolomic features From enrollment until delivery
Secondary Son's gut microbiome metagenomic features The evaluation of the effect of Mediterranean Diet during pregnancy on the son's gut microbiome metagenomic features During the 24 months of life
Secondary Son's gut microbiome metabolomic features The evaluation of the effect of Mediterranean Diet during pregnancy on the son's gut microbiome metabolomic features During the 24 months of life
Secondary Breastfeeding duration The evaluation of the effect of Mediterranean Diet during pregnancy on the breastfeeding duration During the 24 months of life
Secondary Breast milk composition The evaluation of the effect of Mediterranean Diet during pregnancy on the breast milk composition During the 24 months of life
Secondary Epigenetic modulation of genes involved in the regulation of immune system in the offspring The evaluation of the effect of Mediterranean Diet during pregnancy on the epigenetic modulation of genes involved in the regulation of immune system in the offspring Delivery
Secondary Epigenetic modulation of genes involved in the metabolic pathways in the offspring The evaluation of the effect of Mediterranean Diet during pregnancy on the epigenetic modulation of genes involved in the metabolic pathways in the offspring Delivery
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