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New treatment option for Infant, Newborn
Official title Infant Microbiota Restoration With Maternal Microbes
ClinicalTrials.gov ID: NCT07212361
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 50. Healthy volunteers may be eligible.
You may be able to join if
- Healthy mother and healthy pregnancy
- Singleton pregnancy,
- Mothers who speak Finnish or Swedish
- Mothers who are planning to breastfeed or give breastmilk by bottle to the infant
- Infants who are expected to be healthy and who will not require BCG vaccination.
You likely can't join if
- Participants who lives further than a 2-hour drive from Meilahti, Helsinki, Finland
- Mothers who are not planning to breastfeed or feed breastmilk by bottle to the infant
- Mothers who are diagnosed with gestational diabetes, pre-eclampsia or who have been receiving antibiotics during the pregnancy or delivery
- Premature infants born before the pregnancy week 37
- Infants, who are born by urgent cesarean section or emergency cesarean section
- Infants, who receive antibiotics during the first week of life
See the full eligibility criteria
- Healthy mother and healthy pregnancy
- Singleton pregnancy,
- Mothers who speak Finnish or Swedish
- Mothers who are planning to breastfeed or give breastmilk by bottle to the infant
- Infants who are expected to be healthy and who will not require BCG vaccination.
- Participants who lives further than a 2-hour drive from Meilahti, Helsinki, Finland
- Mothers who are not planning to breastfeed or feed breastmilk by bottle to the infant
- Mothers who are diagnosed with gestational diabetes, pre-eclampsia or who have been receiving antibiotics during the pregnancy or delivery
- Premature infants born before the pregnancy week 37
- Infants, who are born by urgent cesarean section or emergency cesarean section
- Infants, who receive antibiotics during the first week of life
- Infants, who are diagnosed with a disease, congenital anomaly or who receive less than 9 Apgar points at 5 minutes.
- Infants, who receive BCG-vaccine
The study team makes the final eligibility decision.
Where it's taking place
- Helsinki, Finland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsinki, Finland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.