Infant Microbiota Restoration With Maternal Microbes

NCT07212361 | Recruiting

• 1 other identifier: HUS/617/2025/71
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Infant, Newborn; Gut -Microbiota; Gut Dysbiosis; Cesarean Delivery Affecting Newborn; Cesarean Section; Vaginal Delivery; Gastrointestinal Microbiota; Microbiota, Cesarean Section, Probiotics, Dysbiosis; Feces; Delivery, Obstetric; Microbiota; Microbiology; Humans; Pregnancy; Neonate

Keywords

Infant; newborn; cesarean section; neonate; restore; gut microbiota

Outcome Measures

Primary Outcomes (2)

• Microbiota composition, relative and absolute abundances

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

  1 week, 5 weeks, 11 weeks, 26 weeks and 52 weeks.

• Fecal metabolite profiles

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

  1 week, 5 weeks, 11 weeks, 26 weeks and 52 weeks

Study Arms (6)

Probiotic

ACTIVE COMPARATOR

The infants will receive a mixture of probiotic strains currently on the market and with known safety profiles and beneficial effects on infant gut microbiota.

Dietary Supplement: Probiotic

Vaginal delivery

NO INTERVENTION

Maternal bacteria set 1

EXPERIMENTAL

The infants will receive a micture of bacteria isolated from a fecal sample of the infants' own mother.

Dietary Supplement: Probiotic

Maternal bacteria set 2

EXPERIMENTAL

The infants will receive a mixture of bacterial species with increased diversity isolated from the mother's sample.

Dietary Supplement: Probiotic

Maternal bacteria set 3

OTHER

The infants will receive a mixture of bacterial strains isolated from other infants' and/or mothers' samples to test whether bacteria from an unrelated donor have different effects compared to maternal bacteria. In this group all infants will receive the same standardised mixture of bacterial strains.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

C-section born infants given a placebo treatment.

Other: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

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

Maternal bacteria set 1; Maternal bacteria set 2; Maternal bacteria set 3; Probiotic

Placebo OTHER

Infant formula without bacteria.

Placebo

Eligibility Criteria

• Age: Up to 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Helsinki: lead
• Helsinki University Central Hospital: collaborator

Study Sites (2)

Helsinki University Hospital

Helsinki, Finland

RECRUITING

University of Helsinki

Helsinki, Finland

RECRUITING

MeSH Terms

Conditions

Dysbiosis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Katri E Korpela, PhD

CONTACT

+358504486369; katri.korpela@helsinki.fi

Marjo Metsäranta, MD, PhD

CONTACT

marjo.metsaranta@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 8, 2025
• Study Start: July 17, 2025
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: October 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)