Prenatal Antibiotics and Breast Milk / Neonatal IgA

Dysbiosis Clinical Trial

— PAIGAN 1  

Official title:

Effect of Prenatal Antibiotics on Breast Milk Immune Function and on the Development of Neonatal Intestinal Immune System: the Role of IgA

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05813184
• Other study ID #: 6530
• Status: Not yet recruiting
• Start date: April 30, 2023
• Est. completion date: October 30, 2025

Study information

• Verified date: April 2023
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Carlo Pietrasanta, MD,PhD
• Phone: +393337505802
• Email: carlo.pietrasanta[@]unimi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this biological study, we 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

Description:

In a human cohort of women and their neonates, we aim to evaluate the absolute amount of IgA in maternal breast milk and in neonatal feces in the presence (N=41 mother/infant pairs) or in the absence (N=41 mother/infant pairs) of exposure to prenatal ABX during the last period of pregnancy. Moreover, we aim to evaluate, both in maternal breast milk and in neonatal feces, the composition of microbiota, and the proportion and composition of the IgA-coated and not-IgA- coated fractions of microbiota, by means of fluorescence-activated cell sorting (FACS) coupled with 16S rRNA sequencing of bacteria. Finally, we will measure the concentration of the chemokine CCL28 on maternal serum and breast milk, as a soluble marker of activity of the entero-mammary pathway that is known to drive the migration of IgA producing plasma- cells from maternal mesenteric lymph nodes to the mammary gland.

All the analysis will be performed in mother-infant dyads with exclusive breastfeeding. Breast milk/serum/feces collection and analysis will be repeated at the following timepoints:

1. during the first week of neonatal life

2. at 1 month of life

3. at 3 months of life

4. at 8-12 months of life (or at the time of breastfeeding interruption), after the introduction of solid food in the infant's diet.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 82
• Est. completion date: October 30, 2025
• Est. primary completion date: April 30, 2025
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

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), and the intention to breastfeed their neonates as long as possible during the first year of life

Exclusion Criteria:

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 and the administration of antibiotics to neonates after birth, within the first week of life.

Related Conditions & MeSH terms

• Antibiotic Prophylaxis
• Dysbiosis
• Neonatal Infection
• Prenatal Exposure Delayed Effects

Intervention

Drug:
• Antibiotics
Any antibiotic therapy administered > 7 days

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	Humanitas Hospital, Italy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	breast milk IgA	concentration of IgA in breast milk	until 12 months of neonatal life
Secondary	fecal IgA	concentration of IgA in neonatal feces	until 12 months of neonatal life
Secondary	breast milk microbiota	Composition of microbiota in breast milk and analysis of fractions coated or uncoated by IgA	until 12 months of neonatal life
Secondary	fecal microbiota	Composition of microbiota in breast milk and analysis of fractions coated or uncoated by IgA	until 12 months of neonatal life
Secondary	maternal CCL28	concentration of CCL28 in maternal serum and breast milk	until 12 months of neonatal life