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

Infant Development Clinical Trial

— TIGER  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05363553
• Other study ID #: DGC202106
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Colic
• Colic, Infantile
• Constipation
• Constipation - Functional
• Digestive System Diseases
• Gastroesophageal Reflux
• Gastrointestinal Diseases
• Gastrointestinal Disorder, Functional
• Infant Development
• Laryngopharyngeal Reflux
• Regurgitation, Gastric

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