Table 1

Inclusion and exclusion criteria of the missing microbes in infants born by Caesarean section (MiMIC) study

Inclusion criteriaExclusion criteria
1. Pregnant females of age 22–40 years.1. Infants admitted to the neonatal unit in receipt of intravenous antibiotics and/or phototherapy.
2. Singleton pregnancy.2. Any infant with suspected chromosomal/genetic condition.
3. Infants born within the Cork University Maternity Hospital, Ireland.3. Any infant with cholestasis or requires mechanical ventilation.
4. Women who are intending to exclusively breastfeed their infant for a minimum of 6 weeks.4. Stillbirth or live birth where the baby is born alive but dies shortly after.
5. Mothers who give birth to full-term infants greater than 35 weeks’ gestation.5. Infants born less than 35 (34 weeks+6 days) weeks’ gestation.
6. Infants who are born healthy with no underlying illness, syndrome or chronic disease.6. Infants who are formula-fed exclusively before 6 weeks of age.
7. Participants who agree to maintain their usual dietary habits throughout the trial period.7. Mothers with insulin-dependent gestational diabetes.
8. Ability of the participant (in the investigator’s opinion) to comprehend the full nature and purpose of the study including possible risks and side effects.8. Mothers and infants who will live more than 40 km from the hospital on discharge.
9. Consent to participate in the study and willingness to comply with the protocol and study restrictions.9. Self-declared history of alcohol abuse (for females: >3 drinks on any single day and >7 drinks per week.
10. Self-declared use of illicit drugs.
11. Participants under administrative or legal supervision.
12. Participation in another study with any investigational product within 60 days of screening.
13. Investigator believes that the participant may be uncooperative and/or non-compliant and should therefore not participate in the study.