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

Recruiting now

Conditions studied: Functional Gastrointestinal Disorders, Gastroesophageal Reflux, Constipation - Functional, Diarrhea, Dyschezia, Colic, Infantile, Vomiting; Cyclical

In brief

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.

Key facts

Study ID

NCT06031025

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

71

Starts

2022-05-20

Expected to finish

2025-09-30

Last updated by the study team

2025-03-11

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• infants with gestational age at birth < 31 weeks
• infants with gestational age at birth < 37 weeks and major respiratory or neurologic morbidity
• infants with history of perinatal asphyxia

You may not qualify if…

• lack of informed consent
• diagnosis of congenital or other major gastrointestinal disease (i.e. inflammatory bowel disease, cancer)

Where it is running

• Fondazione Policlinico Gemelli IRCCS — Roma, Italy (enrolling)

Full record on ClinicalTrials.gov

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