Preterm Infant Intestinal Microbiota Development and Maternal Fecal Transplant

NCT06227845 | Not Yet Recruiting

• 1 other identifier: HUS/1978/2023
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Premature infant; Fecal microbiota transplant; Cesarean section; Immune system development

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• 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.

  6 months

Study Arms (3)

Intervention

EXPERIMENTAL

10 infants born by CS to screening negative mothers receive an oral maternal fecal transplant (from their own mother) containing 0.35mg/kg of maternal fecal content at the age of 2-7 days of age.

Other: Fecal microbiota transplant

Control

NO INTERVENTION

12 infants born by CS (8 to screening negative mothers and 4 to screening positive mothers in case of Blastocystis hominis or Dientamoeba fragilis).

Comparison

NO INTERVENTION

Infants born vaginally to mothers with screening negative or mild pathogene findings (Blastocystis hominis or Dientamoeba fragilis)

Interventions

Fecal microbiota transplant OTHER

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otto Helve: lead
• Karolinska Institutet: collaborator
• University of Helsinki: collaborator

Study Sites (1)

Helsinki University Hospital

Helsinki, Uusimaa, Finland

Location

Related Publications (6)

• Carpen N, Brodin P, de Vos WM, Salonen A, Kolho KL, Andersson S, Helve O. Transplantation of maternal intestinal flora to the newborn after elective cesarean section (SECFLOR): study protocol for a double blinded randomized controlled trial. BMC Pediatr. 2022 Sep 29;22(1):565. doi: 10.1186/s12887-022-03609-3.

  PMID: 36175995 BACKGROUND

• Korpela K, de Vos WM. Early life colonization of the human gut: microbes matter everywhere. Curr Opin Microbiol. 2018 Aug;44:70-78. doi: 10.1016/j.mib.2018.06.003. Epub 2018 Aug 4.

  PMID: 30086431 BACKGROUND

• Van Belkum M, Mendoza Alvarez L, Neu J. Preterm neonatal immunology at the intestinal interface. Cell Mol Life Sci. 2020 Apr;77(7):1209-1227. doi: 10.1007/s00018-019-03316-w. Epub 2019 Oct 1.

  PMID: 31576423 BACKGROUND

• Olin A, Henckel E, Chen Y, Lakshmikanth T, Pou C, Mikes J, Gustafsson A, Bernhardsson AK, Zhang C, Bohlin K, Brodin P. Stereotypic Immune System Development in Newborn Children. Cell. 2018 Aug 23;174(5):1277-1292.e14. doi: 10.1016/j.cell.2018.06.045.

  PMID: 30142345 BACKGROUND

• Forsgren M, Isolauri E, Salminen S, Rautava S. Late preterm birth has direct and indirect effects on infant gut microbiota development during the first six months of life. Acta Paediatr. 2017 Jul;106(7):1103-1109. doi: 10.1111/apa.13837. Epub 2017 Apr 24.

  PMID: 28316118 BACKGROUND

• Korpela K, Helve O, Kolho KL, Saisto T, Skogberg K, Dikareva E, Stefanovic V, Salonen A, Andersson S, de Vos WM. Maternal Fecal Microbiota Transplantation in Cesarean-Born Infants Rapidly Restores Normal Gut Microbial Development: A Proof-of-Concept Study. Cell. 2020 Oct 15;183(2):324-334.e5. doi: 10.1016/j.cell.2020.08.047. Epub 2020 Oct 1.

  PMID: 33007265 RESULT

MeSH Terms

Conditions

Communicable Diseases; Premature Birth

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Otto Helve, Docent

  University of Helsinki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noora K Carpén, MD

CONTACT

+358 9 4711; noora.carpen@hus.fi

Samuli Rautava, Associate Professor

CONTACT

+358 9 4711; samuli.rautava@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Docent

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: February 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)