NCT04079335 - 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)

D'Haens G, Ferrante M, Vermeire S, Baert F, Noman M, Moortgat L, Geens P, Iwens D, Aerden I, Van Assche G, Van Olmen G, Rutgeerts P
Fecal calprotectin is a surrogate marker for endoscopic lesions in inflammatory bowel disease. Inflamm Bowel Dis. 2012 Dec;18(12):2218-24. doi: 10.1002/ibd.22917. Epub 2012 Feb 16.
García-Sánchez V, Iglesias-Flores E, González R, Gisbert JP, Gallardo-Valverde JM, González-Galilea A, Naranjo-Rodríguez A, de Dios-Vega JF, Muntané J, Gómez-Camacho F
Does fecal calprotectin predict relapse in patients with Crohn's disease and ulcerative colitis? J Crohns Colitis. 2010 Jun;4(2):144-52. doi: 10.1016/j.crohns.2009.09.008. Epub 2009 Dec 2.
Hanaway P, Roseth A
Inflammatory biomarkers predict relapse in IBD. Gut. 2005 Sep;54(9):1346-7.
McIlroy J, Ianiro G, Mukhopadhya I, Hansen R, Hold GL
Review article: the gut microbiome in inflammatory bowel disease-avenues for microbial management. Aliment Pharmacol Ther. 2018 Jan;47(1):26-42. doi: 10.1111/apt.14384. Epub 2017 Oct 16. Review.
Pascal V, Pozuelo M, Borruel N, Casellas F, Campos D, Santiago A, Martinez X, Varela E, Sarrabayrouse G, Machiels K, Vermeire S, Sokol H, Guarner F, Manichanh C
A microbial signature for Crohn's disease. Gut. 2017 May;66(5):813-822. doi: 10.1136/gutjnl-2016-313235. Epub 2017 Feb 7.
Sartor RB, Wu GD
Roles for Intestinal Bacteria, Viruses, and Fungi in Pathogenesis of Inflammatory Bowel Diseases and Therapeutic Approaches. Gastroenterology. 2017 Feb;152(2):327-339.e4. doi: 10.1053/j.gastro.2016.10.012. Epub 2016 Oct 18. Review.

A Prospective Longitudinal Study of Fecal Microbiome and Calprotectin to Predict Relapse in Patients With Inflammatory Bowel Disease

Details for clinical trial NCT04079335

Clinical trial NCT04079335 - References