Preterm Infant Intestinal Microbiota Development and Maternal Fecal Transplant
ConditionMicrobial Colonization
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOtto Helve
About this trial
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.
Eligibility criteria
Qualifiers
Pregnant women with preeclampsia or other risk factors of preterm labor (eg cervix insufficiency or placenta previa) between 29+0 - 34+0 weeks of pregnancy.
Either parent fluent in Finnish.
Disqualifiers
Women with other significant medical conditions including acute infection, IBD, celiac disease.
Travelling outside the EU and use of antibiotics during the last 3 months.
Gestational diabetes with insulin medication.
Pregnant with multiples.
Trial design
Treatments tested in this trial
- Fecal microbiota transplant
Treatment groups
36 Participants
are divided into 3 treatment groupsSponsors and collaborators
Otto Helve
Lead sponsor
Helsinki University Central Hospital
Sponsor institution
Karolinska Institutet
Collaborator
University of Helsinki
Collaborator
Source ClinicalTrials.gov