Infant Microbiota Restoration With Maternal Microbes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 50
SponsorUniversity of Helsinki

About this trial

The goal of this clinical trial is to test the ability of different bacterial products in restoring natural gut microbiota in C-section born infants. The main question it aims to answer is:

Do maternally derived strains of bacteria perform better than commercially available probiotic strains in restoring the gut microbiota of C-section born infants? Researchers will compare the gut microbiota of treated infants to that of untreated C-section born infants and untreated vaginally born infants to see if the bacterial treatments cause the microbiota to resemble that of vaginally born infants.

Participants will be given a bacterial product orally once daily for either one or four weeks and be asked to collect faecal, urine and saliva samples.

Eligibility criteria

Qualifiers

Healthy mother and healthy pregnancy

Singleton pregnancy,

Mothers who speak Finnish or Swedish

Mothers who are planning to breastfeed or give breastmilk by bottle to the infant

Disqualifiers

Participants who lives further than a 2-hour drive from Meilahti, Helsinki, Finland

Mothers who are not planning to breastfeed or feed breastmilk by bottle to the infant

Mothers who are diagnosed with gestational diabetes, pre-eclampsia or who have been receiving antibiotics during the pregnancy or delivery

Premature infants born before the pregnancy week 37

Trial design

Treatments tested in this trial

  • Probiotic
  • Placebo

Treatment groups

100 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

University of Helsinki

Lead sponsor

Helsinki University Central Hospital

Collaborator