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

NCT06031025 | Recruiting

• 1 other identifier: 4921
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Prevalence of FGID

  Occurrence of FGID (percentage of patients)

  3, 6, 12, 24 months of corrected age

• Frequency of FGID

  Frequency of FGID (i.e. number of symptoms per day)

  3, 6, 12, 24 months of corrected age

• Severity of FGID

  Severity (scales from 0 to 10 for increasing values) of FGID

  3, 6, 12, 24 months of corrected age

Secondary Outcomes (3)

• Somatic growth: weight

  3, 6, 12, 24 months of corrected age

• Somatic growth: head circumference

  3, 6, 12, 24 months of corrected age

• Somatic growth: length

  3, 6, 12, 24 months of corrected age

Interventions

Questionnaire, clinical examination OTHER

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.

Eligibility Criteria

• Age: 3 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants matching the inclusion criteria will be enrolled in the local Follow-up program (as per clinical routine of the local Institution).

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)

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 32446468 RESULT

• Robin 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.

  PMID: 29398057 RESULT

• Benninga 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.

  PMID: 27144631 RESULT

• Iacono 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.

  PMID: 15893282 RESULT

• Scarpato 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.

  PMID: 36705695 RESULT

MeSH Terms

Conditions

Gastrointestinal Diseases; Gastroesophageal Reflux; Diarrhea; Constipation; Colic; Familial cyclic vomiting syndrome

Interventions

Surveys and Questionnaires; Restraint, Physical

Condition Hierarchy (Ancestors)

Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Study Officials

• Stefano Nobile, MD, PhD, MSc

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Nobile, MD, PhD, MSc

CONTACT

+390630156937; stefano.nobile@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 11, 2023
• Study Start: May 20, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

IT (1)