NCT04037826 - 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)

Didari T, Mozaffari S, Nikfar S, Abdollahi M
Effectiveness of probiotics in irritable bowel syndrome: Updated systematic review with meta-analysis. World J Gastroenterol. 2015 Mar 14;21(10):3072-84. doi: 10.3748/wjg.v21.i10.3072.
McFarland LV, Dublin S
Meta-analysis of probiotics for the treatment of irritable bowel syndrome. World J Gastroenterol. 2008 May 7;14(17):2650-61. doi: 10.3748/wjg.14.2650.
Moayyedi P, Ford AC, Talley NJ, Cremonini F, Foxx-Orenstein AE, Brandt LJ, Quigley EM
The efficacy of probiotics in the treatment of irritable bowel syndrome: a systematic review. Gut. 2010 Mar;59(3):325-32. doi: 10.1136/gut.2008.167270. Epub 2008 Dec 17
Tiequn B, Guanqun C, Shuo Z
Therapeutic effects of Lactobacillus in treating irritable bowel syndrome: a meta-analysis. Intern Med. 2015;54(3):243-9. doi: 10.2169/internalmedicine.54.2710.
Zhang Y, Li L, Guo C, Mu D, Feng B, Zuo X, Li Y
Effects of probiotic type, dose and treatment duration on irritable bowel syndrome diagnosed by Rome III criteria: a meta-analysis. BMC Gastroenterol. 2016 Jun 13;16(1):62. doi: 10.1186/s12876-016-0470-z.

Randomized Clinical Trial on the Safety and Efficacy of L. Reuteri DSM 17938 and L. Reuteri ATCC PTA 6475 in the Treatment of Moderate to Severe Irritable Bowel Syndrome in Adults. Version 1.0, CSUB 0137, 27Jun2017

Details for clinical trial NCT04037826

Clinical trial NCT04037826 - References