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

NCT06031025 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 71

Last updated 2025-03-11

No results posted yet for this study

Summary

The goal of this observational study is to learn about the prevalence and characteristics of functional gastrointestinal disorders (FGID) in at risk infants (former preterm infants and those with birth asphyxia) during the first 2 years of life. The main questions it aims to answer are:

* evaluate the prevalence of symptoms related to gastro-esophageal reflux (GER), of functional gastrointestinal disorders during the first 2 years of life
* describe growth parameters during follow-up up to the corrected age of 2 years Participants will be assessed clinically and with a structured questionnaire based on the Rome IV criteria to describe FGID.

Conditions

  • Functional Gastrointestinal Disorders
  • Gastroesophageal Reflux
  • Constipation - Functional
  • Diarrhea
  • Dyschezia
  • Colic, Infantile
  • Vomiting; Cyclical

Interventions

OTHER

Questionnaire, clinical examination

At each follow up visit, a clinical examination and anthropometric evaluation will be performed. Parents will fill a structured questionnaire to describe the occurrence and characteristics of functional gastrointestinal disorders.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Stefano Nobile, MD, PhD, MSc · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Eligibility

Min Age
3 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-20
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06031025 on ClinicalTrials.gov