Functional Gastrointestinal DisordersFUSIDNCT06031025
Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.
An observational study of Functional Gastrointestinal Disorders and Gastroesophageal Reflux, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 24 months
- Conditions the study is for
- Functional Gastrointestinal Disorders, Gastroesophageal Reflux, Constipation - Functional
- What is being tested?
- Questionnaire, clinical examination
- How many people
- 71 participants
- Where
- 1 siteItaly
- Study dates
- 20 May 2022to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants matching the inclusion criteria will be enrolled in the local Follow-up program (as per clinical routine of the local Institution).
Who may be able to join
- 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
Who cannot join
- lack of informed consent
- diagnosis of congenital or other major gastrointestinal disease (i.e. inflammatory bowel disease, cancer)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Gemelli IRCCS
Roma, 00168
Stefano Nobile, MD, PhD, MSc, +390630156937, stefano.nobile@policlinicogemelli.it
About this study
Official title: Prospective Assessment of the Prevalence and Natural History of Gastroesophageal Reflux and Functional Gastro-intestinal Disorders Among At-risk Infants
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.
Read the detailed description
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).
- Conditions
- Functional Gastrointestinal Disorders, Gastroesophageal Reflux, Constipation - Functional, Diarrhea, Dyschezia, Colic, Infantile
- Being tested
- Questionnaire, clinical examination
- Medical subject headings
- Gastrointestinal Diseases, Gastroesophageal Reflux, Diarrhea, Constipation, Colic, Familial cyclic vomiting syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire, clinical examinationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of FGID
Occurrence of FGID (percentage of patients)
Measured: 3, 6, 12, 24 months of corrected age
Frequency of FGID
Frequency of FGID (i.e. number of symptoms per day)
Measured: 3, 6, 12, 24 months of corrected age
Severity of FGID
Severity (scales from 0 to 10 for increasing values) of FGID
Measured: 3, 6, 12, 24 months of corrected age
Secondary outcomes (3)
Somatic growth: weight
Measurement of weight and calculation of z-scores based on reference standards by the World Health Organization
Measured: 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
Measured: 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
Measured: 3, 6, 12, 24 months of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start20 May 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Nobile, MD, PhD, MSc, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031025
- Sponsor's protocol ID
- 4921
- Acronym
- FUSID
- Status last verified
- Mar 2025
- First submitted
- 28 Aug 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Steutel NF, Zeevenhooven J, Scarpato E, Vandenplas Y, Tabbers MM, Staiano A, Benninga MA. Prevalence of Functional Gastrointestinal Disorders in European Infants and Toddlers. J Pediatr. 2020 Jun;221:107-114. doi: 10.1016/j.jpeds.2020.02.076.
PubMed 32446468Robin SG, Keller C, Zwiener R, Hyman PE, Nurko S, Saps M, Di Lorenzo C, Shulman RJ, Hyams JS, Palsson O, van Tilburg MAL. Prevalence of Pediatric Functional Gastrointestinal Disorders Utilizing the Rome IV Criteria. J Pediatr. 2018 Apr;195:134-139. doi: 10.1016/j.jpeds.2017.12.012. Epub 2018 Feb 3.
PubMed 29398057Benninga MA, Faure C, Hyman PE, St James Roberts I, Schechter NL, Nurko S. Childhood Functional Gastrointestinal Disorders: Neonate/Toddler. Gastroenterology. 2016 Feb 15:S0016-5085(16)00182-7. doi: 10.1053/j.gastro.2016.02.016. Online ahead of print.
PubMed 27144631Iacono G, Merolla R, D'Amico D, Bonci E, Cavataio F, Di Prima L, Scalici C, Indinnimeo L, Averna MR, Carroccio A; Paediatric Study Group on Gastrointestinal Symptoms in Infancy. Gastrointestinal symptoms in infancy: a population-based prospective study. Dig Liver Dis. 2005 Jun;37(6):432-8. doi: 10.1016/j.dld.2005.01.009. Epub 2005 Mar 2.
PubMed 15893282Scarpato E, Salvatore S, Romano C, Bruzzese D, Ferrara D, Inferrera R, Zeevenhooven J, Steutel NF, Benninga MA, Staiano A. Prevalence and Risk Factors of Functional Gastrointestinal Disorders: A Cross-Sectional Study in Italian Infants and Young Children. J Pediatr Gastroenterol Nutr. 2023 Feb 1;76(2):e27-e35. doi: 10.1097/MPG.0000000000003653. Epub 2022 Nov 1.
PubMed 36705695
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of the Prevalence and Natural History of Gastroesophageal Reflux and Functional Gastro-intestinal Disorders Among At-risk Infants
- ClinicalTrials.gov ID
- NCT06031025
- Acronym / sponsor ID
- FUSID / 4921
- Conditions
- Functional Gastrointestinal Disorders, Gastroesophageal Reflux, Constipation - Functional, Diarrhea, Dyschezia, Colic, Infantile
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants matching the inclusion criteria will be enrolled in the local Follow-up program (as per clinical routine of the local Institution).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- lack of informed consent
- diagnosis of congenital or other major gastrointestinal disease (i.e. inflammatory bowel disease, cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire, clinical examinationAt 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. | Other | – |
Primary outcome
Prevalence of FGID
Time frame: 3, 6, 12, 24 months of corrected age
Occurrence of FGID (percentage of patients)
Frequency of FGID
Time frame: 3, 6, 12, 24 months of corrected age
Frequency of FGID (i.e. number of symptoms per day)
Severity of FGID
Time frame: 3, 6, 12, 24 months of corrected age
Severity (scales from 0 to 10 for increasing values) of FGID
3 secondary outcomes
Somatic growth: weight
Time frame: 3, 6, 12, 24 months of corrected age
Somatic growth: head circumference
Time frame: 3, 6, 12, 24 months of corrected age
Somatic growth: length
Time frame: 3, 6, 12, 24 months of corrected age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Results publication: PubMed 32446468Steutel NF, Zeevenhooven J, Scarpato E, Vandenplas Y, Tabbers MM, Staiano A, Benninga MA. Prevalence of Functional Gastrointestinal Disorders in European Infants and Toddlers. J Pediatr. 2020 Jun;221:107-114. doi: 10.1016/j.jpeds.2020.02.076.
- Results publication: PubMed 29398057Robin SG, Keller C, Zwiener R, Hyman PE, Nurko S, Saps M, Di Lorenzo C, Shulman RJ, Hyams JS, Palsson O, van Tilburg MAL. Prevalence of Pediatric Functional Gastrointestinal Disorders Utilizing the Rome IV Criteria. J Pediatr. 2018 Apr;195:134-139. doi: 10.1016/j.jpeds.2017.12.012. Epub 2018 Feb 3.
- Results publication: PubMed 27144631Benninga MA, Faure C, Hyman PE, St James Roberts I, Schechter NL, Nurko S. Childhood Functional Gastrointestinal Disorders: Neonate/Toddler. Gastroenterology. 2016 Feb 15:S0016-5085(16)00182-7. doi: 10.1053/j.gastro.2016.02.016. Online ahead of print.
- Results publication: PubMed 15893282Iacono G, Merolla R, D'Amico D, Bonci E, Cavataio F, Di Prima L, Scalici C, Indinnimeo L, Averna MR, Carroccio A; Paediatric Study Group on Gastrointestinal Symptoms in Infancy. Gastrointestinal symptoms in infancy: a population-based prospective study. Dig Liver Dis. 2005 Jun;37(6):432-8. doi: 10.1016/j.dld.2005.01.009. Epub 2005 Mar 2.
- Results publication: PubMed 36705695Scarpato E, Salvatore S, Romano C, Bruzzese D, Ferrara D, Inferrera R, Zeevenhooven J, Steutel NF, Benninga MA, Staiano A. Prevalence and Risk Factors of Functional Gastrointestinal Disorders: A Cross-Sectional Study in Italian Infants and Young Children. J Pediatr Gastroenterol Nutr. 2023 Feb 1;76(2):e27-e35. doi: 10.1097/MPG.0000000000003653. Epub 2022 Nov 1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefano Nobile, MD, PhD, MSc principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Gastrointestinal Disorders and Gastroesophageal Reflux, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Nobile, MD, PhD, MSc (+390630156937, stefano.nobile@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of FGID (time frame: 3, 6, 12, 24 months of corrected age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06031025, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.