GrowthPhase 2/3NCT06312059
Goat or Cow Milk Based Infant Formula GMS
A Phase 2/3 study testing Advance Infant Formula Powder, "Kendamil Cow milk test product and "Kendamil goat milk test product in people with Growth, run by Kendal Nutricare Ltd at 1 site in United States.
Trial summary
This study is a non-inferiority, decentralized, randomized, double-blind, controlled clinical trial evaluating the growth, tolerance, and safety of a goat's-milk test infant formula (Test Formula 1; TF1) and a cow's-milk test infant formula (Test Formula 2; TF2), each compared to a cow's-milk infant formula… Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Growth
- What is being tested?
- Advance Infant Formula Powder, "Kendamil Cow milk test product and "Kendamil goat milk test product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 409 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2023to 15 Aug 2024
- Phase
- Phase 2/3
- 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 Up to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy term infants (37 to 42 weeks gestation at birth) from a singleton birth as assessed by the investigator
- Infants with a birth weight of >2500 g to <4500 g
- Infants ≤11 days of age at enrollment; birth constitutes Day 0
- Parent/legal guardian who has previously decided to exclusively feed infant formula and is willing to continue with formula feeding throughout the study
Who cannot join
- A participant who meets any of the following criteria will be excluded from participation in the study:
- Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
- Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth
- Infant has been treated with prescription medications that in the Investigator's opinion could impact growth, gastrointestinal tolerance and/or development
- Infant that has received oral or parenteral antibiotics prior to enrollment
- Infant is taking and parent/legal guardian plans to continue (including over-the-counter medications, such as Mylicon® for gas), home remedies (such as juice for constipation), gastroesophageal reflux medications, herbal preparations, or rehydration fluids that, in the Investigator's opinion, might affect gastrointestinal tolerance. Use of the following are strongly discouraged for the duration of the trial:
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- Solid foods and juices
- Vitamins and/mineral supplements, as the study product provided is nutritionally complete
- Pre- and probiotics
- Infant with family history (biological siblings or parents) of confirmed milk protein allergy (Parent's lactose intolerance is not disqualifying)
- Parent(s)/Legal guardian(s) intent on feeding non-study formula, breastmilk, juices, or solid food during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Growth Tolerance and Safety Study of Healthy Term Infants Consuming a Goat or Cow Milk Based Infant Formula
This study is a non-inferiority, decentralized, randomized, double-blind, controlled clinical trial evaluating the growth, tolerance, and safety of a goat's-milk test infant formula (Test Formula 1; TF1) and a cow's-milk test infant formula (Test Formula 2; TF2), each compared to a cow's-milk infant formula commercially available in the United States (Control Formula; CF).
- Conditions
- Growth
- Being tested
- Advance Infant Formula Powder, "Kendamil Cow milk test product, "Kendamil goat milk test product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance Infant Formula PowderOther
Sole source infant nutrition for the control arm.
"Kendamil Cow milk test productOther
Sole source infant nutrition for the cow milk test arm.
"Kendamil goat milk test productOther
Sole source infant nutrition for the goat milk test arm.
| Study group | Role | What they receive |
|---|---|---|
| Market leader- Competitor Cow Milk based infant formula | Active comparator | Intervention with Competitor product currently in market- Control. Receives: Other: Advance Infant Formula Powder |
| Test product Cow Milk based infant formula | Experimental | Intervention with Test product product - Test arm. Receives: Other: "Kendamil Cow milk test product |
| Test product Goat Milk based infant formula | Experimental | Intervention with Test product product - Test arm. Receives: Other: "Kendamil goat milk test product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth as compared against WHO growth charts
Mean daily weight gain for infants fed TF1 and infants fed TF2, each compared to infants fed CF, from baseline through to Week 16
Measured: 16 weeks
Secondary outcomes (1)
Safety
Adverse Events reported over the 16-week study period (+4 days) for all groups
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start14 Dec 2023
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GrowthStudies 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 2/3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kendal Nutricare Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ObvioHealth
- Responsible party
- Sponsor
- Investigators
- Allan Soo, Principal investigator, MD, FAPCR ObvioHealth USA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312059
- Sponsor's protocol ID
- KNC-GMS-002
- Status last verified
- Mar 2026
- First submitted
- 4 Jan 2024
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Information to be shared with regulatory agencies.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Tolerance and Safety Study of Healthy Term Infants Consuming a Goat or Cow Milk Based Infant Formula
- ClinicalTrials.gov ID
- NCT06312059
- Acronym / sponsor ID
- KNC-GMS-002
- Conditions
- Growth
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Kendal Nutricare LtdIndustry (pharma, biotech, devices)
- Collaborators
- ObvioHealth
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 15 Mar 2024 (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.
This study is a non-inferiority, decentralized, randomized, double-blind, controlled clinical trial evaluating the growth, tolerance, and safety of a goat's-milk test infant formula (Test Formula 1; TF1) and a cow's-milk test infant formula (Test Formula 2; TF2), each compared to a cow's-milk infant formula commercially available in the United States (Control Formula; CF).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Market leader- Competitor Cow Milk based infant formula | Active comparator | Other: Advance Infant Formula PowderIntervention with Competitor product currently in market- Control. |
| Test product Cow Milk based infant formula | Experimental | Other: "Kendamil Cow milk test productIntervention with Test product product - Test arm. |
| Test product Goat Milk based infant formula | Experimental | Other: "Kendamil goat milk test productIntervention with Test product product - Test arm. |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy term infants (37 to 42 weeks gestation at birth) from a singleton birth as assessed by the investigator
- Infants with a birth weight of >2500 g to <4500 g
- Infants ≤11 days of age at enrollment; birth constitutes Day 0
- Parent/legal guardian who has previously decided to exclusively feed infant formula and is willing to continue with formula feeding throughout the study
Key exclusion criteria (11 listed)
- A participant who meets any of the following criteria will be excluded from participation in the study:
- Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
- Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth
- Infant has been treated with prescription medications that in the Investigator's opinion could impact growth, gastrointestinal tolerance and/or development
- Infant that has received oral or parenteral antibiotics prior to enrollment
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 |
|---|---|---|
| Advance Infant Formula PowderSole source infant nutrition for the control arm. | Other | Market leader- Competitor Cow Milk based infant formula |
| "Kendamil Cow milk test productSole source infant nutrition for the cow milk test arm. | Other | Test product Cow Milk based infant formula |
| "Kendamil goat milk test productSole source infant nutrition for the goat milk test arm. | Other | Test product Goat Milk based infant formula |
Primary outcome
Growth as compared against WHO growth charts
Time frame: 16 weeks
Mean daily weight gain for infants fed TF1 and infants fed TF2, each compared to infants fed CF, from baseline through to Week 16
1 secondary outcome
Safety
Time frame: 16 weeks
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 24 Mar 2026.
- Individual participant dataSharing planned: No. Information to be shared with regulatory agencies.
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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.
Allan Soo principal investigator
MD, FAPCR ObvioHealth USA, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Advance Infant Formula Powder, "Kendamil Cow milk test product and "Kendamil goat milk test product in people with Growth, run by Kendal Nutricare Ltd at 1 site in United States.
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 4 inclusion and 11 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 24 Mar 2026. 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Growth as compared against WHO growth charts (time frame: 16 weeks). 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 24 Mar 2026.