GrowthNCT06137235
Effects of an Infant Formula and follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections
A study testing cows milk infant formula and follow-on formula with bioactive ingredients and standard cows milk infant formula and follow-on formula in people with Growth and Infections, run by FrieslandCampina at 3 sites in Greece.
Trial summary
In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF. Read more about this study
- Who is it for?
- Ages 5 to 60 daysHealthy volunteers can take part
- Conditions the study is for
- Growth, Infections
- What is being tested?
- cows milk infant formula and follow-on formula with bioactive ingredients and standard cows milk infant formula and follow-on formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 3 sitesGreece
- Study dates
- 18 Dec 2023to Dec 2027
- Phase
- Interventional
- 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 5 to 60 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full-term infants
- Healthy birthweight: 2500 g ≤ birthweight ≤ 4200 g
- Boys and girls
- Apparently healthy at birth and screening
- Weight-for-age Z-score (WAZ) at screening within the normal range according to WHO Child Growth Standards
- Age at enrolment: ≤60 days of age
Show all 10Show fewer
- If age at inclusion ≤1 month: infants exclusively formula fed for at least 5 days prior to inclusion
- If 1 month < age at inclusion ≤ 2 months: infants exclusively formula fed since 1 month old2
- Being available for follow up until the age of 12 months
- Written informed consent from parent(s) and/or legal guardian(s) aged ≥18 years
Who cannot join
- Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy (CMA), lactose intolerance and diagnosed medical conditions that are known to affect study outcomes (e.g. functional gastro-intestinal disorders (FGID))
- 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 only formula for their child until the age of 12 months
- Infants fed a special diet other than standard cow's or goat's milk based (non-hydrolyzed) infant formula prior to inclusion
Trial locations and contacts
3 sites in 1 country.
Greece3 sites
Harokopio University
Athens
International Hellenic University
Thessaloniki
University of Thessaly
Trikala
About this study
Official title: A Randomized, Controlled, Double-blind Parallel Group Trial to Study the Effects of an Infant Formula and a follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections in Healthy Term Infants
In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF.
Read the detailed description
In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF, until the age of 1y. 456 healthy term infants who are exclusively formula-fed will be included <2mo of age. An exploratory follow-up assessment will be done at the age of 2 and 3 years to study sustained health effects.
- Conditions
- Growth, Infections
- Being tested
- cows milk infant formula and follow-on formula with bioactive ingredients, standard cows milk infant formula and follow-on formula
- Keywords
- infant nutrition, growth, gut comfort, product tolerance, infections
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cows milk infant formula and follow-on formula with bioactive ingredientsOther
infant formula and follow-on formula with bioactive ingredients
standard cows milk infant formula and follow-on formulaOther
standard cows milk infant formula and follow-on formula
| Study group | Role | What they receive |
|---|---|---|
| test formula | Experimental | infant formula and follow-on formula with bioactive ingredients Receives: Other: cows milk infant formula and follow-on formula with bioactive ingredients |
| control formula | Active comparator | standard infant formula and follow-on formula Receives: Other: standard cows milk infant formula and follow-on formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
weight for age, compared to WHO growth curve, for test group only
Measured: until age of 6 months
infection-related morbidity episodes, parent-reported
number of parental-reported respiratory and gut infection-related symptoms, compared between test and control group
Measured: 6 - 12 months of age
Secondary outcomes (9)
weight
weight for age, compared to WHO growth curve, for control group
Measured: until the age of 6 months
length
length in cm
Measured: until the age of 6 months
head circumference
head circumference in cm
Measured: until the age of 6 months
BMI
BMI in kg/m2
Measured: until the age of 6 months
product tolerance: GI comfort
GI comfort questionnaire
Measured: until the age of 6 months
product tolerance: stool frequency and consistency
stool frequency and consistency questionnaire
Measured: until the age of 6 months
product tolerance: product intake
product intake (ml/feeding, ml/day)
Measured: until the age of 6 months
Duration of infection-related episodes
duration of parental-reported respiratory and gut infection-related symptoms in summed days
Measured: 6 - 12 months of age
infection-related morbidity episodes, physician-diagnosed
number of physician-diagnosed respiratory and gut infection-related symptoms
Measured: 6 - 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start18 Dec 2023
- Primary completion31 Dec 2025
- Study completionDec 2027 (estimated)
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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FrieslandCampina
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yannis Manios, Prof, Principal investigator, Harokopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137235
- Sponsor's protocol ID
- Armadillo
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2023
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 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 and a follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections in Healthy Term Infants
- ClinicalTrials.gov ID
- NCT06137235
- Acronym / sponsor ID
- Armadillo
- Conditions
- Growth, Infections
- Keywords
- infant nutrition, growth, gut comfort, product tolerance, infections
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- FrieslandCampinaIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Nov 2023 (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.
In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF.
Detailed description
In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF, until the age of 1y. 456 healthy term infants who are exclusively formula-fed will be included <2mo of age. An exploratory follow-up assessment will be done at the age of 2 and 3 years to study sustained health effects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test formula | Experimental | Other: cows milk infant formula and follow-on formula with bioactive ingredientsinfant formula and follow-on formula with bioactive ingredients |
| control formula | Active comparator | Other: standard cows milk infant formula and follow-on formulastandard infant formula and follow-on formula |
Who may qualify
- Ages
- 5 to 60 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Full-term infants
- Healthy birthweight: 2500 g ≤ birthweight ≤ 4200 g
- Boys and girls
- Apparently healthy at birth and screening
- Weight-for-age Z-score (WAZ) at screening within the normal range according to WHO Child Growth Standards
Key exclusion criteria (6 listed)
- Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy (CMA), lactose intolerance and diagnosed medical conditions that are known to affect study outcomes (e.g. functional gastro-intestinal disorders (FGID))
- 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 only formula for their child until the age of 12 months
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 |
|---|---|---|
| cows milk infant formula and follow-on formula with bioactive ingredientsinfant formula and follow-on formula with bioactive ingredients | Other | test formula |
| standard cows milk infant formula and follow-on formulastandard cows milk infant formula and follow-on formula | Other | control formula |
Primary outcome
weight
Time frame: until age of 6 months
weight for age, compared to WHO growth curve, for test group only
infection-related morbidity episodes, parent-reported
Time frame: 6 - 12 months of age
number of parental-reported respiratory and gut infection-related symptoms, compared between test and control group
9 secondary outcomes
weight
Time frame: until the age of 6 months
length
Time frame: until the age of 6 months
head circumference
Time frame: until the age of 6 months
BMI
Time frame: until the age of 6 months
product tolerance: GI comfort
Time frame: until the age of 6 months
product tolerance: stool frequency and consistency
Time frame: until the age of 6 months
product tolerance: product intake
Time frame: until the age of 6 months
Duration of infection-related episodes
Time frame: 6 - 12 months of age
infection-related morbidity episodes, physician-diagnosed
Time frame: 6 - 12 months of age
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 29 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Yannis Manios, Prof principal investigator
Harokopio University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cows milk infant formula and follow-on formula with bioactive ingredients and standard cows milk infant formula and follow-on formula in people with Growth and Infections, run by FrieslandCampina at 3 sites in Greece.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece. 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?
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?
weight (time frame: until age of 6 months). The study lists 2 primary outcomes in all. 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 29 Jan 2026.