An observational study in Gastrointestinal Symptoms, Infection and Allergy Symptoms, sponsored by Ausnutria Hyproca B.V.. Active, not recruiting at 3 sites in Saudi Arabia. Open to participants aged Up to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by Ausnutria Hyproca B.V. · Observational
A retrospective observational medical dossier-based study to assess gastrointestinal discomfort and infections in healthy term infants
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 300 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Ausnutria Hyproca B.V. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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The study population consists of 300 healthy term infants with medical dossiers covering the period of 0-12 months of age and at least 6 clinic visits.
Exclusion Criteria:
Formula-fed infants either goat milk-based infant formula or cow's milk-based infant formula
Other: Infants fed goat milk-based infant formula
Type of infant feeding during the age of 0-12 months
Also known as: Infants fed cow's milk based infant formula, Infants breastfed / human milk feeding
To investigate the occurrence of symptoms related to GI discomfort in formula-fed infants in the Gulf region
To determine the number of symptoms related to GI discomfort in formula-fed infants between 0-12 months of age
Time frame: retrospective infants from 0 - 12 months of age
Plan to share: No
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This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Ausnutria Hyproca B.V.