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Completed

NCT Number: NCT05363553

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

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.

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Key information

Conditions

Gastrointestinal Disorder, Functional Colic Colic, Infantile Congenital, Hereditary, and Neonatal Diseases and Abnormalities Constipation - Functional Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Infant Development Infant, Newborn, Diseases Laryngeal Diseases Laryngopharyngeal Reflux Regurgitation, Gastric Respiratory Tract Diseases

Age range

2 week–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Nutrition Research Unit, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital

Bangkok, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infant formula based on whole goat milk

Dietary Supplement

Infant formula based on whole goat milk, nutritionally suitable for infants aged 0-6 months

infant formula based on cow milk proteins

Dietary Supplement

Infant formula based on cow milk proteins, nutritionally suitable for infants aged 0-6 months

Primary outcomes

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

    Time frame: From Day 0 to Day 28

    Parental diary record of number of regurgitation per day reviewed at Day 0, Day 14 and Day 28

Secondary outcomes

  1. Frequency of infant regurgitation

    Time frame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks

    Rome IV criteria diagnosed by physician

  2. Frequency of infant colic

    Time frame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks

    Rome IV criteria diagnosed by physician

  3. Frequency of functional constipation

    Time frame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks

    Rome IV criteria diagnosed by physician

  4. Stool consistency

    Time frame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks

    Stool consistency based on Brussels infants and toddler stool scale (BITSS)

  5. Stool frequency

    Time frame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks

    Number of defecations per day

  6. Feeding difficulties

    Time frame: Day 0, Day 14, Day 28, and Age 8, 16 and 24 weeks

    NeoEAT questionnaire

  7. Sleep

    Time frame: Day 0, Day 28, and Age 12 and 24 weeks

    Brief Infant Sleep questionnaire

  8. Biochemical and metabolic markers: saliva markers

    Time frame: Day 0 and Day 14

    Saliva: inflammation markers (including enzymes reported in U/mL)

  9. Biochemical and metabolic markers: saliva markers

    Time frame: Day 0 and Day 14

    Saliva: stress markers (including hormones reported in ng/mL)

  10. Biochemical and metabolic markers: saliva markers

    Time frame: Day 0 and Day 14

    Saliva: inflammation markers (including proteins reported in µg/mL)

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • Chulalongkorn University

Registry information

Acronym: TIGER

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 6, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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