NCT06031025 - 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:S0016-5085(16)00182-7. doi: 10.1053/j.gastro.2016.02.016. Online ahead of print.
Iacono G, Merolla R, D'Amico D, Bonci E, Cavataio F, Di Prima L, Scalici C, Indinnimeo L, Averna MR, Carroccio A; Paediatric Study Group on Gastrointestinal Symptoms in Infancy
Gastrointestinal symptoms in infancy: a population-based prospective study. D
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: 1
Scarpato E, Salvatore S, Romano C, Bruzzese D, Ferrara D, Inferrera R, Zeevenhooven J, Steutel NF, Benninga MA, Staiano A
Prevalence and Risk Factors of Functional Gastrointestinal Disorders: A Cross-Sectional Study in Italian Infants and Young Children.
Steutel NF, Zeevenhooven J, Scarpato E, Vandenplas Y, Tabbers MM, Staiano A, Benninga MA
Prevalence of Functional Gastrointestinal Disorders in European Infants and Toddlers. J Pediatr. 2020 Jun;221:107-114. doi: 10.1016/j.jpeds.2020.02.076.

Prospective Assessment of the Prevalence and Natural History of Gastroesophageal Reflux and Functional Gastro-intestinal Disorders Among At-risk Infants

Details for clinical trial NCT06031025

Clinical trial NCT06031025 - References