Infant ALLPhase 3NCT07867509
A Clinical Trial on the Effect of Infant Formula Consumption on Growth, Immune Parameters, and Gut Health in Healthy Term Infants
A Phase 3 study testing Infant Formula and Breastfeeding in people with Infant ALL, run by FrieslandCampina.
Trial summary
The goal of this clinical trial is to study growth (weight gain per day) in healthy full-term infants who consume the investigational infant formula containing beneficial ingredients against infants consuming a control infant formula. Read more about this study
- Who is it for?
- Ages Up to 21 daysHealthy volunteers can take part
- Conditions the study is for
- Infant ALL
- What is being tested?
- Infant Formula and Breastfeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 387 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 21 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full-term infants (born between gestational age ≥ 37 weeks[Lv45.1] - 42 weeks).
- Healthy birthweight (according to WHO Child Growth Standards): 2500 g ≤ birthweight ≤ 4200 g (corresponding to Z-scores between the range of -2 SD and +2 SD)
- Boys and girls
- Apparently healthy at birth and screening
- Weight-for-age Z-score (WAZ) at screening within the healthy range according to WHO Child Growth Standards (i.e. -2 SD ≤WAZ≤ 2SD)
- Age at enrolment: ≤21 days of age[Lv46.1]
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- For formula groups: Infants should be exclusively formula fed for at least 3 days prior to inclusion.
- For breastfed group: exclusively breastfeeding infant and the intention to keep exclusively breastfeeding during study period
- Being available for follow up during the duration of the study
- Written informed consent from parent(s) and/or legal guardian(s) aged ≥18 years
- Intention to exclusively feed infant milk (formula or human milk). No weaning during study period.
Who cannot join
- Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy, lactose intolerance and diagnosed medical conditions that are known to affect study outcomes (e.g. GI disorders, growth, immune-related diseases)
- Incapability of parents to comply with the study protocol
- Illiterate parents (i.e. not able to read and write in local language)
- Participation in another clinical trial
- Unwillingness to accept the formula supplied by the study as the sole source of nutrition for their child until the end of the study period
- Past use of supplementation with probiotic supplements (e.g. Biogaia ProTectis Baby Drops, ProBiovit, Intermed Biolact) or infant formula containing probiotics or any specialties IFT [(partially) hydrolysates, comfort formula, etc.]
- Antibiotic use in the first month of life (except exposure resulting from maternal peripartum antibiotic administration, which will be recorded)
- Multiple gestation (e.g. twins, triplets or higher-order multiple births)
About this study
Official title: A Randomized, Controlled, Double-blind Parallel Group Trial to Study the Effects of an Infant Formula Containing Bio-active Ingredients on Immune Parameters, Gut Health and Growth in Healthy Term Infants
The goal of this clinical trial is to study growth (weight gain per day) in healthy full-term infants who consume the investigational infant formula containing beneficial ingredients against infants consuming a control infant formula.
The key secondary outcome is to study sIgA levels from faecal samples at endline while controlling for baseline levels.
Parents of the enrolled infants will be asked to complete a diary, let their infant undergo physical examinations and complete questionnaire and feed their infant the assigned infant formula
- Conditions
- Infant ALL
- Being tested
- Infant Formula, Breastfeeding
- Keywords
- infant formula, infants, growth, immune parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant FormulaCombination product
the experimental formula contains milk fat, MFGM, Lactoferrin, GOS and 2'FL
Infant FormulaCombination product
Standard infant formula complying to (inter-)national legislation
BreastfeedingCombination product
Exclusively breastfeeding
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Infant formula with additional beneficial ingredients Receives: Combination Product: Infant Formula |
| Control | Active comparator | infant formula without additional beneficial ingredients Receives: Combination Product: Infant Formula |
| Reference | Other | Breastfeeding Receives: Combination Product: Breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth
weight gain per day
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant ALLStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 387 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FrieslandCampina
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867509
- Sponsor's protocol ID
- Beetle
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on GDPR legislation, potential patent application
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double-blind Parallel Group Trial to Study the Effects of an Infant Formula Containing Bio-active Ingredients on Immune Parameters, Gut Health and Growth in Healthy Term Infants
- ClinicalTrials.gov ID
- NCT07867509
- Acronym / sponsor ID
- Beetle
- Conditions
- Infant ALL
- Keywords
- infant formula, infants, growth, immune parameters
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 387 participants (estimated)
- Lead sponsor
- FrieslandCampinaIndustry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Oct 2026 (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.
The goal of this clinical trial is to study growth (weight gain per day) in healthy full-term infants who consume the investigational infant formula containing beneficial ingredients against infants consuming a control infant formula.
The key secondary outcome is to study sIgA levels from faecal samples at endline while controlling for baseline levels.
Parents of the enrolled infants will be asked to complete a diary, let their infant undergo physical examinations and complete questionnaire and feed their infant the assigned infant formula
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Combination Product: Infant FormulaInfant formula with additional beneficial ingredients |
| Control | Active comparator | Combination Product: Infant Formulainfant formula without additional beneficial ingredients |
| Reference | Other | Combination Product: BreastfeedingBreastfeeding |
Who may qualify
- Ages
- Up to 21 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Full-term infants (born between gestational age ≥ 37 weeks[Lv45.1] - 42 weeks).
- Healthy birthweight (according to WHO Child Growth Standards): 2500 g ≤ birthweight ≤ 4200 g (corresponding to Z-scores between the range of -2 SD and +2 SD)
- Boys and girls
- Apparently healthy at birth and screening
- Weight-for-age Z-score (WAZ) at screening within the healthy range according to WHO Child Growth Standards (i.e. -2 SD ≤WAZ≤ 2SD)
Key exclusion criteria (8 listed)
- Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy, lactose intolerance and diagnosed medical conditions that are known to affect study outcomes (e.g. GI disorders, growth, immune-related diseases)
- Incapability of parents to comply with the study protocol
- Illiterate parents (i.e. not able to read and write in local language)
- Participation in another clinical trial
- Unwillingness to accept the formula supplied by the study as the sole source of nutrition for their child until the end of the study period
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 Formulathe experimental formula contains milk fat, MFGM, Lactoferrin, GOS and 2'FL | Combination product | Intervention |
| Infant FormulaStandard infant formula complying to (inter-)national legislation | Combination product | Control |
| BreastfeedingExclusively breastfeeding | Combination product | Reference |
Primary outcome
Growth
Time frame: 12 weeks
weight gain per day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Undecided. Depending on GDPR legislation, potential patent application
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Infant Formula and Breastfeeding in people with Infant ALL, run by FrieslandCampina.
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 11 inclusion and 8 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: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
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 (time frame: 12 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 19 Oct 2026.