Breast Feeding — Human Milk and Infant Intestinal Microbiome Study
Citation(s)
Jost T, Lacroix C, Braegger CP, Rochat F, Chassard C Vertical mother-neonate transfer of maternal gut bacteria via breastfeeding. Environ Microbiol. 2014 Sep;16(9):2891-904. doi: 10.1111/1462-2920.12238. Epub 2013 Sep 3.
Moore ER, Bergman N, Anderson GC, Medley N Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2016 Nov 25;11:CD003519. Review.
Schloss PD, Iverson KD, Petrosino JF, Schloss SJ The dynamics of a family's gut microbiota reveal variations on a theme. Microbiome. 2014 Jul 21;2:25. doi: 10.1186/2049-2618-2-25. eCollection 2014.
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.
