Microbial Colonization — Preterm Infant Intestinal Microbiota Development and Maternal Fecal Transplant
Citation(s)
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.
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.
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.
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.
Preterm Infant Intestinal Microbiota Development and Maternal Fecal Transplant
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
