Gastrointestinal Symptoms — The Efficacy of Probiotics to Reduce Antepartum Group B Streptococcus Colonization.
Citation(s)
Dunn AB, Hanson L, VandeVusse L, Leslie S Through the Microbial Looking Glass: Premature Labor, Preeclampsia, and Gestational Diabetes: A Scoping Review. J Perinat Neonatal Nurs. 2019 Jan/Mar;33(1):35-51. doi: 10.1097/JPN.0000000000000375.
Hanson L, Vandevusse L, Duster M, Warrack S, Safdar N Feasibility of oral prenatal probiotics against maternal group B Streptococcus vaginal and rectal colonization. J Obstet Gynecol Neonatal Nurs. 2014 May-Jun;43(3):294-304. doi: 10.1111/1552-6909.12308. Epub 2014 Apr 22.
Hanson L, VandeVusse L, Jerme M, Abad CL, Safdar N Probiotics for Treatment and Prevention of Urogenital Infections in Women: A Systematic Review. J Midwifery Womens Health. 2016 May;61(3):339-55. doi: 10.1111/jmwh.12472.
Hanson L, Vandevusse L Probiotics are food; herbs are plants; what's the risk? Informed consent for complementary and integrative therapies. J Perinat Neonatal Nurs. 2010 Jul-Sep;24(3):201-4. doi: 10.1097/JPN.0b013e3181e8f930. No abstract available.
Malloy E, Kates A, Watson L, VandeVusse L, Safdar N, Hanson L Laboratory Analysis Techniques for the Perinatal Microbiome: Implications for Studies of Probiotic Interventions. J Perinat Neonatal Nurs. 2020 Jul/Sep;34(3):239-250. doi: 10.1097/JPN.0000000000000496.
Simonson J, Haglund K, Weber E, Fial A, Hanson L Probiotics for the Management of Infantile Colic: A Systematic Review. MCN Am J Matern Child Nurs. 2021 Mar-Apr 01;46(2):88-96. doi: 10.1097/NMC.0000000000000691.
VandeVusse L, Hanson L, Safdar N Perinatal outcomes of prenatal probiotic and prebiotic administration: an integrative review. J Perinat Neonatal Nurs. 2013 Oct-Dec;27(4):288-301; quiz E1-2. doi: 10.1097/JPN.0b013e3182a1e15d.
The Efficacy of Probiotics to Reduce Antepartum Group B Streptococcus Colonization
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.