NCT02144168 - Clinical Trial References

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.

Citation(s)

Bleichner G, Bléhaut H, Mentec H, Moyse D
Saccharomyces boulardii prevents diarrhea in critically ill tube-fed patients. A multicenter, randomized, double-blind placebo-controlled trial. Intensive Care Med. 1997 May;23(5):517-23.
Bouhnik Y, Attar A, Joly FA, Riottot M, Dyard F, Flourié B
Lactulose ingestion increases faecal bifidobacterial counts: a randomised double-blind study in healthy humans. Eur J Clin Nutr. 2004 Mar;58(3):462-6.
Kapkac, M
, Erikoglu, M., Tuncyurek, P., Ersin, S., Esassolak, M., Alkanat, M., & Sipahioglu, O. (2003). Fiber enriched diets and radiation induced injury of the gut. Nutrition research (New York, N.Y.), 23(1), 77-83
Majid HA, Cole J, Emery PW, Whelan K
Additional oligofructose/inulin does not increase faecal bifidobacteria in critically ill patients receiving enteral nutrition: a randomised controlled trial. Clin Nutr. 2014 Dec;33(6):966-72. doi: 10.1016/j.clnu.2013.11.008. Epub 2013 Nov 16.
Sokol H, Seksik P, Rigottier-Gois L, Lay C, Lepage P, Podglajen I, Marteau P, Doré J
Specificities of the fecal microbiota in inflammatory bowel disease. Inflamm Bowel Dis. 2006 Feb;12(2):106-11.
Whelan K, Judd PA, Preedy VR, Taylor MA
Covert assessment of concurrent and construct validity of a chart to characterize fecal output and diarrhea in patients receiving enteral nutrition. JPEN J Parenter Enteral Nutr. 2008 Mar-Apr;32(2):160-8. doi: 10.1177/0148607108314769.

The Effect of Enteral Nutrition Supplemented With Prebiotics on Colonic Microbiota in the Critically Ill Patients: A Randomized Controlled Trial

Clinical trial NCT02144168 - References