Clinical trial NCT06744699: Assessment of Gastrointestinal Discomfort and Infections in Healthy Term Infants
Official title: A Retrospective Observational Medical Dossier-based Study to Assess Gastrointestinal Discomfort and Infections in Healthy Term Infants
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gastrointestinal Symptoms
Infection
Allergy Symptoms
Growth
Keywords: infant
retrospective
medical dossier-based study
GI symptoms
infection symptoms
allergy symptoms
type of feeding
growth
Lead sponsor: Ausnutria Hyproca B.V.
Sponsor class: INDUSTRY
First posted: 2024-12-20
Enrollment: 300
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To investigate the occurrence of symptoms related to GI discomfort in formula-fed infants in the Gulf region
timeFrame: retrospective infants from 0 - 12 months of age
Secondary outcomes:
Other outcomes:
Locations:
city: Gizan
country: Saudi Arabia
facility: Al Emies hospital
city: Jubail
country: Saudi Arabia
facility: Mana GH Jubail
city: Medina
country: Saudi Arabia
facility: AlAhmady Hospital
Study officials:
References: