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Effect of Mediterranean Diet During Pregnancy on Gut Microbiota and on the Epigenetics

Study Purpose

Food allergies (AA) are adverse reactions to food. Over the last decade, the AA scenario has changed profoundly. In many countries, there has been a significant increase in the prevalence, persistence and severity of AAs and a consequent increase in the socio-economic impact associated with these conditions. For these reasons, there is a strong need to develop effective strategies to prevent these conditions. To date, the AA etiopathogenesis is not yet fully defined. Genetic factors may predispose certain subjects to the development of AA, but these alone can not explain the change observed in the AA scenario over the last few years, renewing interest in environmental factors. Numerous scientific evidence demonstrate the role of eating habits in influencing human health. Many of the effects of the diet on human health are due to a modulation of intestinal microbiosis. The regulation of the immune system is one of the pathways through which dietary modifications from the earliest times of life can alter the susceptibility of the individual to the development of allergic manifestations. The diet during pregnancy and lactation represents the earliest possible influence on the development of the baby's immune system. Observational studies suggest the association between maternal diet during pregnancy and lactation and development of allergic pathologies in the unborn, but the data are still preliminary. Often, other important parameters such as the atopic status of the parents, the type of delivery, the number of brothers, exposure to common allergens, maternal infections or early life, smoking exposure were not taken into account of cigarettes. The Mediterranean diet (MD) is characterized by a high intake of fruit and vegetables, legumes and whole grains combined with a moderate consumption of red wine, and the use of olive oil as the main source of lipids. In some studies adherence to MD was inversely related to the incidence of asthma and allergic rhinitis, especially in children. High adherence to MD was associated with a positive change in intestinal microbiosis and the production of short chain fatty acids (SCFA), particularly butyrate, the main SCFA produced by intestinal fermentation of food fibers. SCFA regulates mucosal integrity and the immunological and non-immunological mechanisms involved in the development of oral tolerance. MD mechanisms during pregnancy in the prevention of childhood allergies are not yet fully known.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 20 Years - 35 Years
Gender Female
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - women - caucasian ethnicity - aged between 20 and 35 years

    Exclusion Criteria:

    - proven presence of infections during pregnancy and at delivery, - twin pregnancy, - ongoing malignancies, - major gastrointestinal tract malformations, - immunodeficiencies, - diabetes and other chronic diseases at each organ or apparatus level, - chronic intestinal inflammatory diseases, - gastrointestinal function disorders, - celiac disease; - history of abdominal surgery with intestinal resection, - neuropsychiatric disorders, - central nervous system disorders, - vegan diet.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Federico II University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Italy

The disease, disorder, syndrome, illness, or injury that is being studied.

Food Allergy
Arms & Interventions


No Intervention: Pregnant women at standard diet

obstetrical and gynecological follow-up

Experimental: Pregnant women at mediterranean diet

obstetrical and gynecological follow-up + nutritional counseling


Behavioral: - mediterranean diet

The Mediterranean diet (MD) is highly regarded as a healthy balanced diet. It is distinguished by a beneficial fatty acid profile that is rich in both monounsaturated and polyunsaturated fatty acids, high levels of polyphenols and other antioxidants, high intake of fiber and other low glycemic carbohydrates, and relatively greater vegetable than animal protein intake. Specifically, olive oil, assorted fruits, vegetables, cereals, legumes, and nuts; moderate consumption of fish, poultry, and red wine; and a lower intake of dairy products, red meat, processed meat and sweets characterize the traditional MD.

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International Sites

University of Naples Federico II, Naples, Italy




University of Naples Federico II

Naples, , 80131

Site Contact

Roberto Berni Canani, MD, PhD



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