NCT05922189 - 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)

Bernstein MT, Graff LA, Targownik LE, Downing K, Shafer LA, Rawsthorne P, Bernstein CN, Avery L
Gastrointestinal symptoms before and during menses in women with IBD. Aliment Pharmacol Ther. 2012 Jul;36(2):135-44. doi: 10.1111/j.1365-2036.2012.05155.x. Epub 2012 May 24.
Bharadwaj S, Kulkarni G, Shen B
Menstrual cycle, sex hormones in female inflammatory bowel disease patients with and without surgery. J Dig Dis. 2015 May;16(5):245-55. doi: 10.1111/1751-2980.12247.
Chang L, Heitkemper MM
Gender differences in irritable bowel syndrome. Gastroenterology. 2002 Nov;123(5):1686-701. doi: 10.1053/gast.2002.36603.
Dajani EZ, Shahwan TG, Dajani NE
Prostaglandins and brain-gut axis. J Physiol Pharmacol. 2003 Dec;54 Suppl 4:155-64.
Elhadd TA, Neary R, Abdu TA, Kennedy G, Hill A, McLaren M, Akber M, Belch JJ, Clayton RN
Influence of the hormonal changes during the normal menstrual cycle in healthy young women on soluble adhesion molecules, plasma homocysteine, free radical markers and lipoprotein fractions. Int Angiol. 2003 Sep;22(3):222-8.
Lim SM, Nam CM, Kim YN, Lee SA, Kim EH, Hong SP, Kim TI, Kim WH, Cheon JH
The effect of the menstrual cycle on inflammatory bowel disease: a prospective study. Gut Liver. 2013 Jan;7(1):51-7. doi: 10.5009/gnl.2013.7.1.51. Epub 2013 Jan 11.
Parlak E, Dagli U, Alkim C, Disibeyaz S, Tunc B, Ulker A, Sahin B
Pattern of gastrointestinal and psychosomatic symptoms across the menstrual cycle in women with inflammatory bowel disease. Turk J Gastroenterol. 2003 Dec;14(4):250-6.

The Effect of SBS Decompression Technique on Gastrointestinal Symptoms During Menstrual Cycle: a Single-blind Randomized Controlled Trial

Details for clinical trial NCT05922189

Clinical trial NCT05922189 - References