NCT05178004 - 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)

Claud EC
Neonatal Necrotizing Enterocolitis -Inflammation and Intestinal Immaturity. Antiinflamm Antiallergy Agents Med Chem. 2009 Sep;8(3):248-259.
Leonard SA, Nowak-Wegrzyn A
Food protein-induced enterocolitis syndrome: an update on natural history and review of management. Ann Allergy Asthma Immunol. 2011 Aug;107(2):95-101; quiz 101, 162. doi: 10.1016/j.anai.2011.06.004. Review.
Venter C, Brown T, Shah N, Walsh J, Fox AT
Diagnosis and management of non-IgE-mediated cow's milk allergy in infancy - a UK primary care practical guide. Clin Transl Allergy. 2013 Jul 8;3(1):23. doi: 10.1186/2045-7022-3-23.

Profiling Stool Cytokines and Microbiome of Infants With Non-IgE-mediated Cow's Milk Protein Allergy Could Explain Its Pathophysiology and be Used as a Non-invasive Diagnostic Method (Melina Study)

Details for clinical trial NCT05178004

Clinical trial NCT05178004 - References