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| Name | Class |
|---|---|
| Humanitas Hospital, Italy | OTHER |
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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
In a human cohort of women and their neonates, the investigators 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, the investigators 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, the investigators 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotics | Drug | Any antibiotic therapy administered > 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| breast milk IgA | concentration of IgA in breast milk | until 12 months of neonatal life |
| Measure | Description | Time Frame |
|---|---|---|
| fecal IgA | concentration of IgA in neonatal feces | until 12 months of neonatal life |
| breast milk microbiota | Composition of microbiota in breast milk and analysis of fractions coated or uncoated by IgA |
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Inclusion Criteria:
Exclusion Criteria:
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pregnancy is a required condition
pregnant women exposed or not exposed to antibiotics in the last trimester of pregnancy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlo Pietrasanta, MD,PhD | Contact | +393337505802 | carlo.pietrasanta@unimi.it |
| Name | Affiliation | Role |
|---|---|---|
| Carlo Pietrasanta, MD,PhD | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Recruiting | Milan | 20122 | Italy |
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| ID | Term |
|---|---|
| D011297 | Prenatal Exposure Delayed Effects |
| D064806 | Dysbiosis |
| ID | Term |
|---|---|
| D049188 | Prenatal Injuries |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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fecal and breast milk microbiota
| until 12 months of neonatal life |
| fecal microbiota | Composition of microbiota in breast milk and analysis of fractions coated or uncoated by IgA | until 12 months of neonatal life |
| maternal CCL28 | concentration of CCL28 in maternal serum and breast milk | until 12 months of neonatal life |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |