Impact of Birth Method on Baby Gut Bacteria and Pain Sensitivity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study follows healthy newborns to see how delivery method alters the early gut microbiome and related systems. Data will be collected from baby stool and clinical assessments to explore links between microbiota composition, immune markers, and visceral sensitivity. The researchers will compare vaginally delivered and cesarean-born infants who are exclusively breastfed and meet other eligibility criteria. No interventions are applied; the study observes natural differences in early life microbial establishment. Findings may help clarify how birth mode affects long-term gut health and immune development.

Why it matters

Who can join: the full rules

Inclusion Criteria of the babies :

* 2 to 4 days old
* Born vaginally or by cesarean section
* Gestational age at birth ≥ 37 weeks of amenorrhea
* Exclusively breastfed
* With no known medical conditions
* Not receiving any medical supplements other than standard vitamins
* Whose mothers did not take antibiotics during the third trimester of pregnancy, other than those administered at the time of the cesarean section
* Whose mothers did not take probiotics during the third trimester of pregnancy
* Whose mothers did not have gestational diabetes
* Whose mothers do not have any known chronic medical conditions
* Whose mothers did not undergo any chronic treatment
* Whose mothers had a body mass index (BMI) below 25 at the start of pregnancy
* Whose mothers provided consent to participate in the study and to have their babies' stool samples collected
* Whose mothers are not deprived of their liberty or under legal guardianship

Exclusion Criteria of the babies :

* Older than 4 days
* Born before 37 weeks of gestation
* Not exclusively breastfed
* Receiving medical supplementation other than conventional vitamins
* With any type of medical condition
* Whose mothers are under 18 years of age
* Whose mothers received antibiotic therapy during the third trimester of pregnancy
* Whose mothers took probiotics during the third trimester of pregnancy
* Whose mothers have a chronic illness
* Whose mothers are undergoing chronic treatment
* Whose mothers developed gestational diabetes
* Whose mothers had a BMI greater than 25 at the start of pregnancy
* Whose mothers did not give consent to participate in the collection of their baby's stool samples
* Whose mothers are deprived of their liberty or under legal guardianship

Where it's running

• Hopital Paris-Saclay (GHNE)
  Orsay, France Recruiting

Study contacts

• Principal investigator: Julie Poline — Hopital Paris-Saclay (GHNE)
• Study coordinator: REBECA MARTIN-ROSIQUE, PhD
• Email: rebeca.martin-rosique@inrae.fr
• Phone: +33 1 34 65 20 98

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.