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 range

24 Months

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT06744699

SponsorAusnutria Hyproca B.V.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-02

View on ClinicalTrials.gov More Gastrointestinal Symptoms trials

Who can participate

Age range

24 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.