NCT06744699

Assessment of Gastrointestinal Discomfort and Infections in Healthy Term Infants

A Retrospective Observational Medical Dossier-based Study to Assess Gastrointestinal Discomfort and Infections in Healthy Term Infants

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Ausnutria Hyproca B.V. · Industry
• Sex: All
• Age: 24 Months
• Healthy volunteers: Accepted

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.

Conditions

• Gastrointestinal Symptoms
• Infection
• Allergy Symptoms
• Growth

Interventions

Type	Name	Description
OTHER	Infants fed goat milk-based infant formula	Type of infant feeding during the age of 0-12 months

Timeline

• Start date: 2024-11-18
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2024-12-20
• Last updated: 2024-12-20

Locations

3 sites across 1 country: Saudi Arabia