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Infant Microbiota Restoration With Maternal Microbes

NCT07212361 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-10-08

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Probiotic

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

OTHER

Placebo

Infant formula without bacteria.

Sponsors & Collaborators

  • Helsinki University Central Hospital

    collaborator OTHER

  • University of Helsinki

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-17
Primary Completion
2035-12-31
Completion
2035-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07212361 on ClinicalTrials.gov