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Preterm Infant Intestinal Microbiota Development and Maternal Fecal Transplant

NCT06227845 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-02-15

No results posted yet for this study

Summary

The goal of this clinical trial is to study if a oral maternal fecal transplant given to a premature infant born by cesarean section (CS) is safe. The investigators will also compare the gut microbiome of the infants to those born by CS and not received the transplant and to premature infants born vaginally.

Conditions

  • Microbial Colonization

Interventions

OTHER

Fecal microbiota transplant

0.1-0.3 ml liquid containing 3.5 mg/ml of maternal fecal content, (0.35mg/kg)

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • University of Helsinki

    collaborator OTHER

  • Otto Helve

    lead OTHER

Principal Investigators

  • Otto Helve, Docent · University of Helsinki

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2026-01-31
Completion
2026-12-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

Companies

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 NCT06227845 on ClinicalTrials.gov