NCT04576845 - 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)

Maslin K, Grundy J, Glasbey G, Dean T, Arshad SH, Grimshaw K, Oliver E, Roberts G, Venter C
Cows' milk exclusion diet during infancy: Is there a long-term effect on children's eating behaviour and food preferences? Pediatr Allergy Immunol. 2016 Mar;27(2)
Meyer R, Rommel N, Van Oudenhove L, Fleming C, Dziubak R, Shah N
Feeding difficulties in children with food protein-induced gastrointestinal allergies. J Gastroenterol Hepatol. 2014 Oct;29(10):1764-9. doi: 10.1111/jgh.12593.
Mukkada VA, Haas A, Maune NC, Capocelli KE, Henry M, Gilman N, Petersburg S, Moore W, Lovell MA, Fleischer DM, Furuta GT, Atkins D
Feeding dysfunction in children with eosinophilic gastrointestinal diseases. Pediatrics. 2010 Sep;126(3):e672-7. doi: 10.15

The Effect of Early Childhood Cow's Milk Allergy Elimination Diet on Eating Behaviors, Nutrition, and Growth Status at Age 2-6

Clinical trial NCT04576845 - References