Chichlowski M, De Lartigue G, German JB, Raybould HE, Mills DA Bifidobacteria isolated from infants and cultured on human milk oligosaccharides affect intestinal epithelial function. J Pediatr Gastroenterol Nutr. 2012 Sep;55(3):321-7. doi: 10.1097/MPG.0b013e31824fb899.
Garrido D, Kim JH, German JB, Raybould HE, Mills DA Oligosaccharide binding proteins from Bifidobacterium longum subsp. infantis reveal a preference for host glycans. PLoS One. 2011 Mar 15;6(3):e17315. doi: 10.1371/journal.pone.0017315.
Garrido D, Ruiz-Moyano S, Mills DA Release and utilization of N-acetyl-D-glucosamine from human milk oligosaccharides by Bifidobacterium longum subsp. infantis. Anaerobe. 2012 Aug;18(4):430-5. doi: 10.1016/j.anaerobe.2012.04.012. Epub 2012 May 9.
Goldsmith F, O'Sullivan A, Smilowitz JT, Freeman SL Lactation and Intestinal Microbiota: How Early Diet Shapes the Infant Gut. J Mammary Gland Biol Neoplasia. 2015 Dec;20(3-4):149-58. doi: 10.1007/s10911-015-9335-2. Epub 2015 Jul 31.
Lewis ZT, Bokulich NA, Kalanetra KM, Ruiz-Moyano S, Underwood MA, Mills DA Use of bifidobacterial specific terminal restriction fragment length polymorphisms to complement next generation sequence profiling of infant gut communities. Anaerobe. 2013 Feb;19:62-9. doi: 10.1016/j.anaerobe.2012.12.005. Epub 2012 Dec 20.
LoCascio RG, Ninonuevo MR, Freeman SL, Sela DA, Grimm R, Lebrilla CB, Mills DA, German JB Glycoprofiling of bifidobacterial consumption of human milk oligosaccharides demonstrates strain specific, preferential consumption of small chain glycans secreted in early human lactation. J Agric Food Chem. 2007 Oct 31;55(22):8914-9. doi: 10.1021/jf0710480. Epub 2007 Oct 5.
Nwosu CC, Strum JS, An HJ, Lebrilla CB Enhanced detection and identification of glycopeptides in negative ion mode mass spectrometry. Anal Chem. 2010 Dec 1;82(23):9654-62. doi: 10.1021/ac101856r. Epub 2010 Nov 4.
O'Sullivan A, Farver M, Smilowitz JT The Influence of Early Infant-Feeding Practices on the Intestinal Microbiome and Body Composition in Infants. Nutr Metab Insights. 2015 Dec 16;8(Suppl 1):1-9. doi: 10.4137/NMI.S29530. eCollection 2015. Erratum In: Nut
Smilowitz JT, Gho DS, Mirmiran M, German JB, Underwood MA Rapid measurement of human milk macronutrients in the neonatal intensive care unit: accuracy and precision of fourier transform mid-infrared spectroscopy. J Hum Lact. 2014 May;30(2):180-9. doi: 10
Zivkovic AM, German JB, Lebrilla CB, Mills DA Human milk glycobiome and its impact on the infant gastrointestinal microbiota. Proc Natl Acad Sci U S A. 2011 Mar 15;108 Suppl 1(Suppl 1):4653-8. doi: 10.1073/pnas.1000083107. Epub 2010 Aug 2.
Functional Deconstruction of Human Milk Oligosaccharides and Lipids
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.