NCT07212361

Infant Microbiota Restoration With Maternal Microbes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Helsinki · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

The gut microbiota has long-term effects on host health especially in early life. Infants receive maternal faecal microbes during vaginal birth, which is prevented by C-section. C-section is associated with increased risk of many chronic diseases, likely because of the disturbed gut microbiota. We recently showed the effectiveness of a faecal microbiota transplant from the infant's own mother in restoring normal gut microbiota in C-section born infants. However, FMT contains a large diversity of unknown microbes, some of which may pose a risk of dangerous infection. A safe and widely applicable infant microbiota restoration method is urgently needed. In this project, we develop a selective microbiota transplant from mother to infant and test its efficacy and safety in a clinical trial. The work is conducted in the Faculty of Medicine, University of Helsinki.

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

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Specific infant-adapted commercially available strains or strains isolated from the infant's mother.
OTHER	Placebo	Infant formula without bacteria.

Timeline

• Start date: 2025-07-17
• Primary completion: 2035-12-31
• Completion: 2035-12-31
• First posted: 2025-10-08
• Last updated: 2025-10-08

Locations

2 sites across 1 country: Finland