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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Fecal microbiota transplant
Other intervention
0.1-0.3 ml liquid containing 3.5 mg/ml of maternal fecal content, (0.35mg/kg)

Treatment groups

36 Participants

are divided into 3 treatment groups

Group A: InterventionExperimental treatment 1 intervention

Group B: ControlNo intervention 0 interventions

Group C: ComparisonNo intervention 0 interventions

Trial outcomes

Primary outcomes

Safety; Incidence of Treatment- Adverse Events eg. infections and increased need for respiratory support

The primary outcome of the study is safety of the transplantation process. The patients are followed with measurements of markers of inflammation (C-reactive protein (CRP) and blood leucocytes) on the day of transplant and three consecutive days. Clinical symptoms of infection are monitored (such as apnea, tachycardia, fever) as well as symptoms of the gastrointestinal tract (vomiting, diarrhea, feeding intolerance). Any suspected adverse events (such as infections, increased need for respiratory support) are recorded.

Time frame

3 months

Secondary outcomes

The secondary outcome is the difference in heterogeneity of the intestinal microbiome between infants receiving transplant and the control subjects at 3 and 6 months of age.

The investigators focus on the diversity, richness, taxonomic diversity, and transfer of specific bacteria from the mother to the newborn.

Time frame

6 months

Sponsors and contacts

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Otto Helve

Lead sponsor

Helsinki University Central Hospital

Sponsor institution

Karolinska Institutet

Collaborator

University of Helsinki