Prenatal Antibiotics and Breast Milk / Neonatal IgA

NCT05813184 | Recruiting

• 1 other identifier: 6530
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

In this biological study, the investigators will evaluate the levels of breast milk IgA, neonatal fecal IgA, and the composition of breast milk and fecal microbiota throughout the first 12 months of life in neonates born to mothers treated or not treated with prenatal antibiotics for at least 7 days after the 32nd weeks of gestation

Conditions

Prenatal Exposure Delayed Effects; Antibiotic Prophylaxis; Dysbiosis; Neonatal Infection; Breast Milk; Noxious Influence, Affecting Fetus

Keywords

IgA; Prenatal antibiotics; breast milk; feces; neonatal immune system

Outcome Measures

Primary Outcomes (1)

• breast milk IgA

  concentration of IgA in breast milk

  until 12 months of neonatal life

Secondary Outcomes (4)

• fecal IgA

  until 12 months of neonatal life

• breast milk microbiota

  until 12 months of neonatal life

• fecal microbiota

  until 12 months of neonatal life

• maternal CCL28

  until 12 months of neonatal life

Study Arms (2)

Control

Women not exposed to antibiotics throughout the entire duration of pregnancy

Prenatal antibiotics

Women exposed to antibiotics for at least 7 days from the 32nd week of gestation

Drug: Antibiotics

Interventions

Antibiotics DRUG

Any antibiotic therapy administered \> 7 days

Prenatal antibiotics

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: pregnancy is a required condition
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women exposed or not exposed to antibiotics in the last trimester of pregnancy

You may qualify if:

• expression of written informed consent
• an antibiotic treatment (any molecule) for at least 7 days consecutively after the 32 weeks of pregnancy (or the absence of exposure to any systemic antibiotic treatment during pregnancy for the control group)
• the intention to breastfeed their neonates as long as possible during the first year of life

You may not qualify if:

• absence of written informed consent
• the intention to formula feed exclusively (or the presence of significant maternal concerns about breastfeeding)
• a maternal antibiotic treatment shorter than 7 days
• the presence of pre-existing maternal immune-mediated disorders (including immunodeficiencies and chronic infectious diseases)
• a delivery at a gestational age \< 34 weeks
• the administration of antibiotics to neonates after birth, within the first week of life.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead
• Humanitas Hospital, Italy: collaborator

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

fecal and breast milk microbiota

MeSH Terms

Conditions

Prenatal Exposure Delayed Effects; Dysbiosis

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Prenatal Injuries; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Carlo Pietrasanta, MD,PhD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo Pietrasanta, MD,PhD

CONTACT

+393337505802; carlo.pietrasanta@unimi.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher, Principal Investigator

Study Record Dates

• First Submitted: April 2, 2023
• First Posted: April 14, 2023
• Study Start: October 8, 2023
• Primary Completion: April 30, 2025
• Study Completion: October 30, 2025
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

IT (1)