Collado MC, Donat E, Ribes-Koninckx C, Calabuig M, Sanz Y Imbalances in faecal and duodenal Bifidobacterium species composition in active and non-active coeliac disease. BMC Microbiol. 2008 Dec 22;8:232. doi: 10.1186/1471-2180-8-232.
De Palma G, Cinova J, Stepankova R, Tuckova L, Sanz Y Pivotal Advance: Bifidobacteria and Gram-negative bacteria differentially influence immune responses in the proinflammatory milieu of celiac disease. J Leukoc Biol. 2010 May;87(5):765-78. doi: 10.1189/jlb.0709471. Epub 2009 Dec 10.
Gerez CL, Rollán GC, de Valdez GF Gluten breakdown by lactobacilli and pediococci strains isolated from sourdough. Lett Appl Microbiol. 2006 May;42(5):459-64.
Medina M, De Palma G, Ribes-Koninckx C, Calabuig M, Sanz Y Bifidobacterium strains suppress in vitro the pro-inflammatory milieu triggered by the large intestinal microbiota of coeliac patients. J Inflamm (Lond). 2008 Nov 3;5:19. doi: 10.1186/1476-9255-5-19.
Nadal I, Donat E, Ribes-Koninckx C, Calabuig M, Sanz Y Imbalance in the composition of the duodenal microbiota of children with coeliac disease. J Med Microbiol. 2007 Dec;56(Pt 12):1669-74. Erratum in: J Med Microbiol. 2008 Mar;57(Pt 3):401. Donant, Esther [corrected to Donat, Ester].
Sander GR, Cummins AG, Henshall T, Powell BC Rapid disruption of intestinal barrier function by gliadin involves altered expression of apical junctional proteins. FEBS Lett. 2005 Aug 29;579(21):4851-5.
Exploratory, Randomized, Double-blind, Placebo-Controlled Study on the Effects of Bifidobacterium Infantis in Active Celiac Disease
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.
