CompletedNot Applicable

Transition to Infant Formula Feeding on Gastrointestinal Regurgitation (TIGER) Study

Thailand146 participantsStarted 2022-05-25

Plain-language summary

To compare the frequency of regurgitation and other digestive outcomes between infants who receive an infant formula based on whole goat milk and an infant formula based on cow milk proteins during the transition period from breastfeeding to formula feeding, using predominantly breastfed infants as a reference group.

Who can participate

Age range

2 Weeks – 4 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: * healthy full-term born infants (≥ 37 weeks + 0 days and \< 41 weeks + 6 days of gestation) * birth weight ≥ 2.5 kg and ≤ 4.5 kg * born from a singleton pregnancy * live in Bangkok or nearby with no plan for geographical migration before 6 months of age * for experimental and active comparator groups only: parent(s) has expressed the intention to partially (in combination with breastfeeding) or fully formula-feed the infant and ready to enroll in the study before the age of 4 months/120 days * for no intervention group only: parent(s) has expressed the intention to predominantly breastfeed (according to study definition) and ready to enroll in the study before the age of 4 months/120 days * infant has been predominantly breastfed for at least 2 weeks before enrollment * parent(s) has sufficient Thai language skills to understand the study information, the informed consent, and to comply with the study procedure * parent(s) is willing and deemed able to fulfil the requirements of the study protocol and procedures * at least one parent is of legal age of consent Exclusion Criteria: * infant has any disorder considered to interfere with nutrition, growth or development of the immune system * participation of the infant in any other interventional trial or participation of the mother in any intervention trial with infant follow-up * for experimental and active comparator groups only: infant has been formula-fed for more than 1 week before enrolment * for e…

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

Change in daily frequency of regurgitation during the transition period from breastfeeding to formula feeding

Timeframe: From Day 0 to Day 28

Trial details

NCT IDNCT05363553

SponsorDairy Goat Co-operative (N.Z.) Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-30

View on ClinicalTrials.gov More Gastrointestinal Disorder, Functional trials