NCT06031025 Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.
| NCT ID | NCT06031025 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Functional Gastrointestinal Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 71 participants |
| Start Date | 2022-05-20 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 71 participants in total. It began in 2022-05-20 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * lack of informed consent * diagnosis of congenital or other major gastrointestinal disease (i.e. inflammatory bowel disease, cancer)
Contact & Investigator
Stefano Nobile, MD, PhD, MSc
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06031025 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 24 Months, studying Functional Gastrointestinal Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06031025 currently recruiting?
Yes, NCT06031025 is actively recruiting participants. Contact the research team at stefano.nobile@policlinicogemelli.it for enrollment information.
Where is the NCT06031025 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06031025 clinical trial?
NCT06031025 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Stefano Nobile, MD, PhD, MSc at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 71 participants.