NCT04388137 - 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)

Benninga MA, Faure C, Hyman PE, St James Roberts I, Schechter NL, Nurko S
Childhood Functional Gastrointestinal Disorders: Neonate/Toddler. Gastroenterology. 2016 Feb 15. pii: S0016-5085(16)00182-7. doi: 10.1053/j.gastro.2016.02.016. [Epub ahead of print]
Robin SG, Keller C, Zwiener R, Hyman PE, Nurko S, Saps M, Di Lorenzo C, Shulman RJ, Hyams JS, Palsson O, van Tilburg MAL
Prevalence of Pediatric Functional Gastrointestinal Disorders Utilizing the Rome IV Criteria. J Pediatr. 2018 Apr;195:134-139. doi: 10.1016/j.jpeds.2017.12.012. Epub 2018 Feb 3.
Rouster AS, Karpinski AC, Silver D, Monagas J, Hyman PE
Functional Gastrointestinal Disorders Dominate Pediatric Gastroenterology Outpatient Practice. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):847-51. doi: 10.1097/MPG.0000000000001023.
Saps M, Moreno-Gomez JE, Ramírez-Hernández CR, Rosen JM, Velasco-Benitez CA
A nationwide study on the prevalence of functional gastrointestinal disorders in school-children. Bol Med Hosp Infant Mex. 2017 Nov - Dec;74(6):407-412. doi: 10.1016/j.bmhimx.2017.05.005. Epub 2017 Sep 1.

Multi-center Study on the Establishment of Diagnostic Criteria System for Pediatric Functional Gastrointestinal Disorders in Mainland China

Clinical trial NCT04388137 - References