NCT03423069 - 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)

González-Castro AM, Martínez C, Salvo-Romero E, Fortea M, Pardo-Camacho C, Pérez-Berezo T, Alonso-Cotoner C, Santos J, Vicario M
Mucosal pathobiology and molecular signature of epithelial barrier dysfunction in the small intestine in irritable bowel syndrome. J Gastroenterol Hepatol. 2017 Jan;32(1):53-63. doi: 10.1111/jgh.13417. Review.
Halmos EP, Power VA, Shepherd SJ, Gibson PR, Muir JG
A diet low in FODMAPs reduces symptoms of irritable bowel syndrome. Gastroenterology. 2014 Jan;146(1):67-75.e5. doi: 10.1053/j.gastro.2013.09.046. Epub 2013 Sep 25.
Lovell RM, Ford AC
Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):712-721.e4. doi: 10.1016/j.cgh.2012.02.029. Epub 2012 Mar 15.
Mazzawi T, El-Salhy M
Changes in duodenal enteroendocrine cells in patients with irritable bowel syndrome following dietary guidance. Exp Biol Med (Maywood). 2017 Jul;242(13):1355-1362. doi: 10.1177/1535370217699537. Epub 2017 Mar 17.
McKee AM, Prior A, Whorwell PJ
Exclusion diets in irritable bowel syndrome: are they worthwhile? J Clin Gastroenterol. 1987 Oct;9(5):526-8.
Mearin Manrique F
Irritable bowel syndrome (IBS) subtypes: Nothing resembles less an IBS than another IBS. Rev Esp Enferm Dig. 2016 Feb;108(2):57-8.
Shepherd SJ, Lomer MC, Gibson PR
Short-chain carbohydrates and functional gastrointestinal disorders. Am J Gastroenterol. 2013 May;108(5):707-17. doi: 10.1038/ajg.2013.96. Epub 2013 Apr 16. Review.

Effects of a Diet Low in Fructose, Oligosaccharides, Disaccharides, Monosaccharides, Alcohols and Polyols in Patients With Irritable Bowel Syndrome Diarrheal Variant Respect to Dietary Advice: Randomized, Single Blind Clinical Trial.

Details for clinical trial NCT03423069

Clinical trial NCT03423069 - References