NCT04102852 - 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)

Derwa Y, Gracie DJ, Hamlin PJ, Ford AC
Systematic review with meta-analysis: the efficacy of probiotics in inflammatory bowel disease. Aliment Pharmacol Ther. 2017 Aug;46(4):389-400. doi: 10.1111/apt.14203. Epub 2017 Jun 27. Review.
Pagnini C, Corleto VD, Martorelli M, Lanini C, D'Ambra G, Di Giulio E, Delle Fave G
Mucosal adhesion and anti-inflammatory effects of Lactobacillus rhamnosus GG in the human colonic mucosa: A proof-of-concept study. World J Gastroenterol. 2018 Nov 7;24(4
Pagnini C, Martorelli M, Lanini C, Delle Fave G
Development of an Ex Vivo Organ Culture Technique to Evaluate Probiotic Utilization in IBD. J Clin Gastroenterol. 2016 Nov/Dec;50 Suppl 2, Proceedings from the 8th Probiotics, Prebiotics & New Foods for Mic

The Role of Lactobacillus Rhamnosus GG (ATCC 53103) in the Modulation of the Inflammatory Process in the Mucosa of Ulcerative Colitis (UC) Patients With Mild-moderate Clinical Activity

Details for clinical trial NCT04102852

Clinical trial NCT04102852 - References