Assessment of Gastrointestinal Discomfort and Infections in Healthy Term Infants

Active, not recruiting

• Conditions: Gastrointestinal Symptoms; Infection; Allergy Symptoms; Growth

• Registration Number: NCT06744699
• Lead Sponsor: Ausnutria Hyproca B.V.

Brief Summary

A retrospective observational medical dossier-based study to assess gastrointestinal discomfort and infections in healthy term infants

Detailed Description

Gastrointestinal (GI) symptoms like regurgitation, unexplained crying and stool issues (diarrhoea or constipation) are common in young infants \<4 months of age due to an immature gut epithelial barrier, immune system and microbiota, with studies indicating prevalences ranging from 25.9%-78%. This retrospective observational medical dossier-based study is designed to determine the occurrence of GI symptoms in healthy term formula-fed infants to confirm reported prevalence of mild GI symptoms by HCPs in Middle East (74%). As a secondary objective, the improvement of confirmed GI symptoms when switched before 4 months of age from a CMF to GMF will be determined. Based on the results of a previous study in infants with confirmed GI symptoms, it is expected that fewer GI symptoms will be scored in medical dossiers of infants after switching from CMF to GMF, with HM as a reference group. Other secondary objectives of this study are to explore differences between healthy term infants that were fed GMF compared to infants fed CMF or HM on immune related outcomes such as infections and allergies, medication use related to infections and/or gastrointestinal discomfort and/or allergies, number of clinic visits, adequate growth and reason of changing infant formula.

Study Timeline

• Study Start: 2024-11-18
• Study First Submitted: 2024-11-19
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Either exclusively formula fed (GMF or CMF; consumption of HM ≤2 weeks is allowed for formula fed infants) OR exclusively breastfed before introduction of complementary feeding.
• Age 12-24 months of age to ensure collection of recent data.
• If required by local regulation or guidelines, written informed consent (ICF) from Investigator (or parent(s) and/or caregiver(s)* aged ≥18 years).
• Singleton, term infants (gestational age ≥ 37 weeks and ≤ 42 weeks).
• At least 6 reported visits to the doctor between 0-12 months of age.

Exclusion Criteria

• Consumed hydrolysed infant formula or other specialty formulas.
• Any current or previous illnesses/conditions and/or known congenital diseases or malformations which could interfere with the study outcomes, as per Investigator's clinical judgement.
• Participation in any clinical trial during first year of life.
• For formula-fed infant, no switch in feeding type after 4 months of age is allowed.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the occurrence of symptoms related to GI discomfort in formula-fed infants in the Gulf region	retrospective infants from 0 - 12 months of age	To determine the number of symptoms related to GI discomfort in formula-fed infants between 0-12 months of age

Trial Locations

Locations (3)

Al Emies hospital; 🇸🇦 Gizan, Saudi Arabia

Mana GH Jubail; 🇸🇦 Jubail, Saudi Arabia

AlAhmady Hospital; 🇸🇦 Medina, Saudi Arabia