An interventional study of Infant formula based on whole goat milk and infant formula based on cow milk proteins in Gastrointestinal Disorder, Functional, Regurgitation, Gastric and Colic, Infantile, sponsored by Dairy Goat Co-operative (N.Z.) Limited. Completed at 1 site in Thailand. Open to participants aged 2 Weeks to 4 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Dairy Goat Co-operative (N.Z.) Limited · Not applicable, Interventional, and Prevention
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.
The study is a randomized, double-blind, parallel-group trial to study the effect of feeding infants goat milk or cow milk formula in the first 6 months of life on the prevalence of functional gastrointestinal disorders and other health outcomes, including gastrointestinal health and sleep during the transition from breastfeeding to formula-feeding. A predominantly breastfed group is used as a reference group.
548 studies on the registry are indexed under Gastrointestinal Diseases; 101 are open to participants now.
This study's enrollment of 146 is above the median of 80 across 388 interventional studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →Dairy Goat Co-operative (N.Z.) Limited is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Infant formula based on whole goat milk
Dietary Supplement: infant formula based on cow milk proteins
Infant formula based on whole goat milk, nutritionally suitable for infants aged 0-6 months
Infant formula based on cow milk proteins, nutritionally suitable for infants aged 0-6 months
Change in daily frequency of regurgitation during the transition period from breastfeeding to formula feeding
Parental diary record of number of regurgitation per day reviewed at Day 0, Day 14 and Day 28
Time frame: From Day 0 to Day 28
Frequency of infant regurgitation
Rome IV criteria diagnosed by physician
Time frame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Frequency of infant colic
Rome IV criteria diagnosed by physician
Time frame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Frequency of functional constipation
Rome IV criteria diagnosed by physician
Time frame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Stool consistency
Stool consistency based on Brussels infants and toddler stool scale (BITSS)
Time frame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Stool frequency
Number of defecations per day
Time frame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Feeding difficulties
NeoEAT questionnaire
Time frame: Day 0, Day 14, Day 28, and Age 8, 16 and 24 weeks
Sleep
Brief Infant Sleep questionnaire
Time frame: Day 0, Day 28, and Age 12 and 24 weeks
Biochemical and metabolic markers: saliva markers
Saliva: inflammation markers (including enzymes reported in U/mL)
Time frame: Day 0 and Day 14
Biochemical and metabolic markers: saliva markers
Saliva: stress markers (including hormones reported in ng/mL)
Time frame: Day 0 and Day 14
Biochemical and metabolic markers: saliva markers
Saliva: inflammation markers (including proteins reported in µg/mL)
Time frame: Day 0 and Day 14
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from May 2022 to primary completion in Apr 2024, 23 months.
Of 149 interventional studies with no phase under Gastrointestinal Diseases, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 23 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Dairy Goat Co-operative (N.Z.) Limited