Gastrointestinal Disorder, FunctionalTIGERNCT05363553
Transition to Infant Formula Feeding on Gastrointestinal Regurgitation (TIGER) Study
A study testing Infant formula based on whole goat milk and infant formula based on cow milk proteins in people with Gastrointestinal Disorder, Functional and Regurgitation, Gastric, run by Dairy Goat Co-operative (N.Z.) Limited at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 2 weeks to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Disorder, Functional, Regurgitation, Gastric, Colic, Infantile
- What is being tested?
- Infant formula based on whole goat milk and infant formula based on cow milk proteins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteThailand
- Study dates
- 25 May 2022to 28 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 weeks to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Pediatric Nutrition Research Unit, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital
Bangkok
About this 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.
Read the detailed 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.
- Conditions
- Gastrointestinal Disorder, Functional, Regurgitation, Gastric, Colic, Infantile, Constipation - Functional, Infant Development
- Being tested
- Infant formula based on whole goat milk, infant formula based on cow milk proteins
- Keywords
- infant formula, goat milk, regurgitation
- Medical subject headings
- Gastrointestinal Diseases, Laryngopharyngeal Reflux, Colic, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formula based on whole goat milkDietary supplement
Infant formula based on whole goat milk, nutritionally suitable for infants aged 0-6 months
infant formula based on cow milk proteinsDietary supplement
Infant formula based on cow milk proteins, nutritionally suitable for infants aged 0-6 months
| Study group | Role | What they receive |
|---|---|---|
| infant formula based on whole goat milk | Experimental | Not described Receives: Dietary Supplement: Infant formula based on whole goat milk |
| Infant formula based on cow milk proteins | Active comparator | Not described Receives: Dietary Supplement: infant formula based on cow milk proteins |
| Predominantly breastmilk | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Day 0 to Day 28
Secondary outcomes (10)
Frequency of infant regurgitation
Rome IV criteria diagnosed by physician
Measured: 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
Measured: 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
Measured: 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)
Measured: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Stool frequency
Number of defecations per day
Measured: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Feeding difficulties
NeoEAT questionnaire
Measured: Day 0, Day 14, Day 28, and Age 8, 16 and 24 weeks
Sleep
Brief Infant Sleep questionnaire
Measured: 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)
Measured: Day 0 and Day 14
Biochemical and metabolic markers: saliva markers
Saliva: stress markers (including hormones reported in ng/mL)
Measured: Day 0 and Day 14
Biochemical and metabolic markers: saliva markers
Saliva: inflammation markers (including proteins reported in µg/mL)
Measured: Day 0 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start25 May 2022
- Primary completion30 Apr 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Disorder, FunctionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dairy Goat Co-operative (N.Z.) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chulalongkorn University
- Responsible party
- Sponsor
- Investigators
- Sirinuch Chomtho, MD, PhD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363553
- Sponsor's protocol ID
- DGC202106
- Acronym
- TIGER
- Status last verified
- Sep 2024
- First submitted
- 21 Apr 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transition to Infant Formula Feeding on Gastrointestinal Regurgitation (TIGER) Study
- ClinicalTrials.gov ID
- NCT05363553
- Acronym / sponsor ID
- TIGER / DGC202106
- Conditions
- Gastrointestinal Disorder, Functional, Regurgitation, Gastric, Colic, Infantile, Constipation - Functional, Infant Development
- Keywords
- infant formula, goat milk, regurgitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Dairy Goat Co-operative (N.Z.) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Chulalongkorn University
- Study start
- 25 May 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| infant formula based on whole goat milk | Experimental | Dietary Supplement: Infant formula based on whole goat milk |
| Infant formula based on cow milk proteins | Active comparator | Dietary Supplement: infant formula based on cow milk proteins |
| Predominantly breastmilk | No intervention | – |
Who may qualify
- Ages
- 2 weeks to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant formula based on whole goat milkInfant formula based on whole goat milk, nutritionally suitable for infants aged 0-6 months | Dietary supplement | infant formula based on whole goat milk |
| infant formula based on cow milk proteinsInfant formula based on cow milk proteins, nutritionally suitable for infants aged 0-6 months | Dietary supplement | Infant formula based on cow milk proteins |
Primary outcome
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
10 secondary outcomes
Frequency of infant regurgitation
Time frame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Frequency of infant colic
Time frame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Frequency of functional constipation
Time frame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Stool consistency
Time frame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Stool frequency
Time frame: Day 0, Day 14, Day 28, and Age 8, 12, 16, 20 and 24 weeks
Feeding difficulties
Time frame: Day 0, Day 14, Day 28, and Age 8, 16 and 24 weeks
Sleep
Time frame: Day 0, Day 28, and Age 12 and 24 weeks
Biochemical and metabolic markers: saliva markers
Time frame: Day 0 and Day 14
Biochemical and metabolic markers: saliva markers
Time frame: Day 0 and Day 14
Biochemical and metabolic markers: saliva markers
Time frame: Day 0 and Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sirinuch Chomtho, MD, PhD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant formula based on whole goat milk and infant formula based on cow milk proteins in people with Gastrointestinal Disorder, Functional and Regurgitation, Gastric, run by Dairy Goat Co-operative (N.Z.) Limited at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daily frequency of regurgitation during the transition period from breastfeeding to formula feeding (time frame: From Day 0 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.