Actively Recruiting

Age: 3Months - 24Months
All Genders
ID06031025

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

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-11

71

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.

Who Can Participate

Age: 3Months - 24Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants with gestational age at birth less than 31 weeks
  • Infants with gestational age at birth less than 37 weeks and major respiratory or neurologic morbidity
  • Infants with history of perinatal asphyxia
Not Eligible

You will not qualify if you...

  • Lack of informed consent
  • Diagnosis of congenital or other major gastrointestinal disease such as inflammatory bowel disease or cancer

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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)

Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Gemelli IRCCS

Roma, Italy, 00168

Actively Recruiting

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Research Team

S

Stefano Nobile, MD, PhD, MSc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Prevalence and Risk Factors of Functional Gastrointestinal Disorders: A Cross-Sectional Study in Italian Infants and Young Children.

Elena Scarpato, Silvia Salvatore, Claudio Romano...

https://pubmed.ncbi.nlm.nih.gov/36705695