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NCT Number: NCT07212361

Infant Microbiota Restoration With Maternal Microbes

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.

Recruiting

Interested in participating?

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Key information

Age range

Up to 50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital, Helsinki, Finland

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About this study

The gut microbiota has long-term effects on host health especially in early life. Infants receive maternal faecal microbes during vaginal birth, which is prevented by C-section. C-section is associated with increased risk of many chronic diseases, likely because of the disturbed gut microbiota. We recently showed the effectiveness of a faecal microbiota transplant from the infant's own mother in restoring normal gut microbiota in C-section born infants. However, FMT contains a large diversity of unknown microbes, some of which may pose a risk of dangerous infection. A safe and widely applicable infant microbiota restoration method is urgently needed. In this project, we develop a selective microbiota transplant from mother to infant and test its efficacy and safety in a clinical trial. The work is conducted in the Faculty of Medicine, University of Helsinki.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Dietary Supplement

Specific infant-adapted commercially available strains or strains isolated from the infant's mother.

Placebo

Other

Infant formula without bacteria.

Primary outcomes

  1. Microbiota composition, relative and absolute abundances

    Time frame: 1 week, 5 weeks, 11 weeks, 26 weeks and 52 weeks.

    Similarity of the overall gut, mouth, and skin microbiota composition

  2. Fecal metabolite profiles

    Time frame: 1 week, 5 weeks, 11 weeks, 26 weeks and 52 weeks

    Fecal metabolite profiles in the treatment groups compared to the vaginally born reference group.

Study contacts

Contact information is provided by the study sponsor or research team.

Katri E Korpela, PhD

CONTACT

[email protected]

+358504486369

Marjo Metsäranta, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

  • Helsinki University Central Hospital

Registry information

Acronym: MaMi

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Oct 8, 2025
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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