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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05363553
Other study ID # DGC202106
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 25, 2022
Est. completion date August 30, 2024

Study information

Verified date May 2024
Source Dairy Goat Co-operative (N.Z.) Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 146
Est. completion date August 30, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Weeks to 4 Months
Eligibility 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 experimental and active comparator groups only: cow milk allergy or intolerance of the infant - for experimental and active comparator groups only: enrolled infant who never consumed any study product until the first visit 2 weeks following enrolment

Study Design


Intervention

Dietary Supplement:
Infant formula based on whole goat milk
Infant formula based on whole goat milk, nutritionally suitable for infants aged 0-6 months
infant formula based on cow milk proteins
Infant formula based on cow milk proteins, nutritionally suitable for infants aged 0-6 months

Locations

Country Name City State
Thailand Pediatric Nutrition Research Unit, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital Bangkok

Sponsors (2)

Lead Sponsor Collaborator
Dairy Goat Co-operative (N.Z.) Limited Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 From Day 0 to Day 28
Secondary Frequency of infant regurgitation Rome IV criteria diagnosed by physician Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Secondary Frequency of infant colic Rome IV criteria diagnosed by physician Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Secondary Frequency of functional constipation Rome IV criteria diagnosed by physician Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Secondary Stool consistency Stool consistency based on Brussels infants and toddler stool scale (BITSS) Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Secondary Stool frequency Number of defecations per day Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Secondary Feeding difficulties NeoEAT questionnaire Day 0, Day 14, Day 28, and Age 8, 16 and 24 weeks
Secondary Sleep Brief Infant Sleep questionnaire Day 0, Day 28, and Age 12 and 24 weeks
Secondary Biochemical and metabolic markers: saliva markers Saliva: inflammation markers (including enzymes reported in U/mL) Day 0 and Day 14
Secondary Biochemical and metabolic markers: saliva markers Saliva: stress markers (including hormones reported in ng/mL) Day 0 and Day 14
Secondary Biochemical and metabolic markers: saliva markers Saliva: inflammation markers (including proteins reported in µg/mL) Day 0 and Day 14
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