NCT02193685 - 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)

Demehri FR, Frykman PK, Cheng Z, Ruan C, Wester T, Nordenskjöld A, Kawaguchi A, Hui TT, Granström AL, Funari V, Teitelbaum DH; HAEC Collaborative Research Group
Altered fecal short chain fatty acid composition in children with a history of Hirschsprung-a
Frykman PK, Cheng Z, Wang X, Dhall D
Enterocolitis causes profound lymphoid depletion in endothelin receptor B- and endothelin 3-null mouse models of Hirschsprung-associated enterocolitis. Eur J Immunol. 2015 Mar;45(3):807-17. doi: 10.1002/eji.201444737. Epub 2015 Jan 19.
Frykman PK, Nordenskjöld A, Kawaguchi A, Hui TT, Granström AL, Cheng Z, Tang J, Underhill DM, Iliev I, Funari VA, Wester T; HAEC Collaborative Research Group (HCRG)
Characterization of Bacterial and Fungal Microbiome in Children with Hirschsprung Disease
Frykman PK, Short SS
Hirschsprung-associated enterocolitis: prevention and therapy. Semin Pediatr Surg. 2012 Nov;21(4):328-35. doi: 10.1053/j.sempedsurg.2012.07.007. Review.

Identification of Genetic, Immunologic and Microbial Markers of Hirschsprung Associated Enterocolitis in Children With Hirschsprung Disease

Clinical trial NCT02193685 - References