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Assessment of Gastrointestinal Discomfort and Infections in Healthy Term Infants

NCT ID: NCT06744699

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-18

Study Completion Date

2025-02-28

Brief Summary

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

Detailed Description

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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

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Gastrointestinal Symptoms Infection Allergy Symptoms Growth

Keywords

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Formula-fed infants

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

Infants fed goat milk-based infant formula

Intervention Type OTHER

Type of infant feeding during the age of 0-12 months

Interventions

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Infants fed goat milk-based infant formula

Type of infant feeding during the age of 0-12 months

Intervention Type OTHER

Other Intervention Names

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Infants fed cow's milk based infant formula Infants breastfed / human milk feeding

Eligibility Criteria

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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.
Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ausnutria Hyproca B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Al Emies hospital

Jizan, , Saudi Arabia

Site Status

Mana GH Jubail

Jubail, , Saudi Arabia

Site Status

AlAhmady Hospital

Madinah, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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P24-151

Identifier Type: -

Identifier Source: org_study_id