An observational study in Functional Gastrointestinal Disorders, Gastroesophageal Reflux and Constipation - Functional, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 3 Months to 24 Months. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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:
Infants will undergo clinical assessment at 3, 6, 12, 24 months' corrected age at the local Follow-up clinic.
Clinical examination, anthropometric measurement and data from a structured questionnaire to detect FGID will be performed.
Z-scores for weight, length and head circumference will be calculated according to the World Health Organization (WHO) standards.
Data from the questionnaires will be collected. Clinical characteristics of patients and perinatal data will be collected and analyzed by appropriate statistical methods.
The prevalence and characteristics of FGID in the study population will be compared to published data (mostly from term infants).
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's planned enrollment of 71 is below the median of 178 across 348 observational studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
Compared within Gastroesophageal Reflux, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Gastrointestinal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Infants matching the inclusion criteria will be enrolled in the local Follow-up program (as per clinical routine of the local Institution).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Prevalence of FGID
Occurrence of FGID (percentage of patients)
Time frame: 3, 6, 12, 24 months of corrected age
Frequency of FGID
Frequency of FGID (i.e. number of symptoms per day)
Time frame: 3, 6, 12, 24 months of corrected age
Severity of FGID
Severity (scales from 0 to 10 for increasing values) of FGID
Time frame: 3, 6, 12, 24 months of corrected age
Somatic growth: weight
Measurement of weight and calculation of z-scores based on reference standards by the World Health Organization
Time frame: 3, 6, 12, 24 months of corrected age
Somatic growth: head circumference
Measurement of head circumference and calculation of z-scores based on reference standards by the World Health Organization
Time frame: 3, 6, 12, 24 months of corrected age
Somatic growth: length
Measurement of length and calculation of z-scores based on reference standards by the World Health Organization
Time frame: 3, 6, 12, 24 months of corrected age
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS →