Prenatal Exposure Delayed EffectsPAIGAN 1NCT05813184
Prenatal Antibiotics and Breast Milk / Neonatal IgA
An observational study of Prenatal Exposure Delayed Effects and Antibiotic Prophylaxis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Prenatal Exposure Delayed Effects, Antibiotic Prophylaxis, Dysbiosis
- What is being tested?
- Antibiotics
- How many people
- 82 participants
- Where
- 1 siteItaly
- Study dates
- 8 Oct 2023to 30 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
Study population: pregnant women exposed or not exposed to antibiotics in the last trimester of pregnancy
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
carlo Pietrasanta, MD, +393337505802, carlo.pietrasanta@gmail.com
About this study
Official title: Effect of Prenatal Antibiotics on Breast Milk Immune Function and on the Development of Neonatal Intestinal Immune System: the Role of IgA
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
Read the detailed description
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:
- during the first week of neonatal life
- at 1 month of life
- at 3 months of life
- at 8-12 months of life (or at the time of breastfeeding interruption), after the introduction of solid food in the infant's diet.
- Conditions
- Prenatal Exposure Delayed Effects, Antibiotic Prophylaxis, Dysbiosis, Neonatal Infection, Breast Milk; Noxious Influence, Affecting Fetus
- Being tested
- Antibiotics
- Keywords
- IgA, Prenatal antibiotics, breast milk, feces, neonatal immune system
- Medical subject headings
- Prenatal Exposure Delayed Effects, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticsDrug
Any antibiotic therapy administered > 7 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
breast milk IgA
concentration of IgA in breast milk
Measured: until 12 months of neonatal life
Secondary outcomes (4)
fecal IgA
concentration of IgA in neonatal feces
Measured: until 12 months of neonatal life
breast milk microbiota
Composition of microbiota in breast milk and analysis of fractions coated or uncoated by IgA
Measured: until 12 months of neonatal life
fecal microbiota
Composition of microbiota in breast milk and analysis of fractions coated or uncoated by IgA
Measured: until 12 months of neonatal life
maternal CCL28
concentration of CCL28 in maternal serum and breast milk
Measured: until 12 months of neonatal life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start8 Oct 2023
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal Exposure Delayed EffectsStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Humanitas Hospital, Italy
- Responsible party
- Principal investigator, Carlo Pietrasanta, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Carlo Pietrasanta, MD,PhD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813184
- Sponsor's protocol ID
- 6530
- Acronym
- PAIGAN 1
- Status last verified
- Jun 2024
- First submitted
- 2 Apr 2023
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prenatal Antibiotics on Breast Milk Immune Function and on the Development of Neonatal Intestinal Immune System: the Role of IgA
- ClinicalTrials.gov ID
- NCT05813184
- Acronym / sponsor ID
- PAIGAN 1 / 6530
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- Humanitas Hospital, Italy
- Study start
- 8 Oct 2023 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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:
- during the first week of neonatal life
- at 1 month of life
- at 3 months of life
- at 8-12 months of life (or at the time of breastfeeding interruption), after the introduction of solid food in the infant's diet.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Women not exposed to antibiotics throughout the entire duration of pregnancy |
| Prenatal antibiotics | – | Drug: AntibioticsWomen exposed to antibiotics for at least 7 days from the 32nd week of gestation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- pregnant women exposed or not exposed to antibiotics in the last trimester of pregnancy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticsAny antibiotic therapy administered > 7 days | Drug | Prenatal antibiotics |
Primary outcome
breast milk IgA
Time frame: until 12 months of neonatal life
concentration of IgA in breast milk
4 secondary outcomes
fecal IgA
Time frame: until 12 months of neonatal life
breast milk microbiota
Time frame: until 12 months of neonatal life
fecal microbiota
Time frame: until 12 months of neonatal life
maternal CCL28
Time frame: until 12 months of neonatal life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Pietrasanta, MD,PhD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prenatal Exposure Delayed Effects and Antibiotic Prophylaxis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlo Pietrasanta, MD,PhD (+393337505802, carlo.pietrasanta@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
breast milk IgA (time frame: until 12 months of neonatal life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.