Assessment of Gastrointestinal Discomfort and Infections in Healthy Term Infants (NCT06744699) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Assessment of Gastrointestinal Discomfort and Infections in Healthy Term Infants
Saudi Arabia300 participantsStarted 2024-11-18
Plain-language summary
A retrospective observational medical dossier-based study to assess gastrointestinal discomfort and infections in healthy term infants
Who can participate
Age range24 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
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