Assessment of Gastrointestinal Discomfort and Infections in Healthy Term Infants

NCT06744699 | Active Not Recruiting

• 1 other identifier: P24-151
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Gastrointestinal Symptoms; Infection; Allergy Symptoms; Growth

Keywords

infant; retrospective; medical dossier-based study; GI symptoms; infection symptoms; allergy symptoms; type of feeding; growth

Outcome Measures

Primary Outcomes (1)

• 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

  retrospective infants from 0 - 12 months of age

Study Arms (1)

Formula-fed infants

Formula-fed infants either goat milk-based infant formula or cow's milk-based infant formula

Other: Infants fed goat milk-based infant formula

Interventions

Infants fed goat milk-based infant formula OTHER

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

Formula-fed infants

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ausnutria Hyproca B.V.: lead

Study Sites (3)

Al Emies hospital

Jizan, Saudi Arabia

Location

Mana GH Jubail

Jubail, Saudi Arabia

Location

AlAhmady Hospital

Madinah, Saudi Arabia

Location

MeSH Terms

Conditions

Infections

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: December 20, 2024
• Study Start: November 18, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (3)