NCT05480059 - 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)

Kibune Nagasako C, Garcia Montes C, Silva Lorena SL, Mesquita MA
Irritable bowel syndrome subtypes: Clinical and psychological features, body mass index and comorbidities. Rev Esp Enferm Dig. 2016 Feb;108(2):59-64.
Lacy BE, Patel NK
Rome Criteria and a Diagnostic Approach to Irritable Bowel Syndrome. J Clin Med. 2017 Oct 26;6(11). pii: E99. doi: 10.3390/jcm6110099. Review.
Lee OY
Prevalence and risk factors of irritable bowel syndrome in Asia. J Neurogastroenterol Motil. 2010 Jan;16(1):5-7. doi: 10.5056/jnm.2010.16.1.5. Epub 2010 Jan 31.

Assessment of Psychological Symptoms and Health Related Quality of Life in Patients With Irritable Bowel Syndrome

Clinical trial NCT05480059 - References