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Infant Microbiota Restoration With Maternal Microbes

RecruitingNAAges any - 50 YearsAllUniversity of Helsinki
NCT07212361 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * Infants who are expected to be healthy and who will not require BCG vaccination. Exclusion Criteria: * 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 * Infants, who are born by urgent cesarean section or emergency cesarean section * Infants, who receive antibiotics during the first week of life * Infants, who are diagnosed with a disease, congenital anomaly or who receive less than 9 Apgar points at 5 minutes. * Infants, who receive BCG-vaccine
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What it tests

  • Probiotic
  • Placebo
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Where

2 sites
Helsinki University Hospital
Helsinki, Finland
University of Helsinki
Helsinki, Finland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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