Prevalence of Pediatric Functional Gastrointestinal Disorders Utilizing the Rome IV Criteria.
Samantha G Robin, Catherine Keller, Russell Zwiener...
https://pubmed.ncbi.nlm.nih.gov/29398057/Actively Recruiting
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-11
71
Participants Needed
1
Research Sites
N/A
Total Duration
This research aims to learn about how common functional gastrointestinal disorders FGID and related symptoms like gastro-esophageal reflux GER are in infants considered at risk, including those born prematurely or with birth asphyxia. The study focuses on infants during their first two years of life, looking closely at the presence and characteristics of these digestive issues as well as growth patterns. Participants will be assessed through clinical examinations and questionnaires based on the Rome IV criteria at 3, 6, 12, and 24 months of corrected age. During these visits, measurements of weight, length, and head circumference will be taken and analyzed according to World Health Organization standards. The data collected will be compared to existing information mostly derived from full-term infants. Throughout the study, infants will undergo regular clinical assessments and parents will complete structured questionnaires to document symptoms and severity of FGID. Researchers will analyze growth metrics and clinical data over time to understand the natural history and prevalence of these disorders in the study population. The total participation spans up to two years, with multiple follow-up visits to track changes and outcomes.
CONDITIONS
Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.
S
Stefano Nobile, MD, PhD, MSc
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 3 months to 24 months of corrected age
Participants undergo clinical assessments including clinical examination, anthropometric measurements, and structured questionnaires to detect functional gastrointestinal disorders.
Visits at 3, 6, 12, and 24 months corrected age (in-person)
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Lead Sponsor