Healthy InfantsNCT07242508
Efficacy of a New Infant Formula Composition on Gut Health in Infants
A study testing Infant Formula and Infant Formula with bioactive ingredients in people with Healthy Infants, run by FrieslandCampina at 1 site in Bulgaria.
Trial summary
The aim of this study is to investigate potential health benefits of the experimental formula. The main objective is whether the experimental formula elevates the relative abundance of Bifidobacterium in stool samples after 10 weeks, as compared a standard formula, aka control formula. Read more about this study
- Who is it for?
- Ages 0 to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- Infant Formula and Infant Formula with bioactive ingredients
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBulgaria
- Study dates
- 25 Nov 2025to 19 Aug 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 0 to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy, full term, infants with a birth weight between 2500-4500 grams
- Parents independently from study decided to not breastfeed their infant
- Parents agree to feed the assigned study formula as the infant's sole source of nutrition for the duration of the study
- have read and voluntarily signed an informed consent form
- parents are capable of completing study procedures required by the protocol
Who cannot join
- suffering from any anatomic and/or physiologic condition that would interfere with normal growth, development or feeding
- are required to take medications or supplements known to influence growth and development
- have a maternal history with known adverse effects on the fetus and/or the newborn infant
- have previous or current antibiotics use (antibiotics administered during delivery are permitted)
- have received or are planning to receive probiotics, prebiotics, or nutritional supplements prior to and throughout the trial (excluding vitamin D and vitamin K supplementation)
- personal history of or parents/siblings diagnosed with cow's milk protein allergy or lactose intolerance
- multiple birth
- participation in another trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bulgaria1 site, 1 recruiting
- Recruiting
Second SAGBAL Sheinovo AD
Sofia
Doctor, 359 883 387 887, frie9383-comms@premier.trialinteractive.com
About this study
Official title: Efficacy of a New Infant Formula Composition on Gut Health in Infants: A Prospective Randomized Double-blind Placebo-controlled Trial
The aim of this study is to investigate potential health benefits of the experimental formula. The main objective is whether the experimental formula elevates the relative abundance of Bifidobacterium in stool samples after 10 weeks, as compared a standard formula, aka control formula. In addition other markers of gut health, such as stool characteristics, and gut health symptoms will be monitored
- Conditions
- Healthy Infants
- Being tested
- Infant Formula, Infant Formula with bioactive ingredients
- Keywords
- infant, formula, microbiota, gut health, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant FormulaOther
ad-libitum consumption of infant formula
Infant Formula with bioactive ingredientsOther
ad-libitum consumption
| Study group | Role | What they receive |
|---|---|---|
| Experimental infant formula | Experimental | Infant formula with bioactive ingredients Receives: Other: Infant Formula with bioactive ingredients |
| Control formula | Placebo comparator | Standard infant formula Receives: Other: Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bifidobacterium
Relative abundance of bifidobacterium from stool samples
Measured: From enrollment to the end of treatment at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start25 Nov 2025
- Primary completion19 Aug 2027 (estimated)
- Study completion19 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy InfantsStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FrieslandCampina
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242508
- Sponsor's protocol ID
- ECCT2831
- Status last verified
- Sep 2026
- First submitted
- 17 Nov 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a New Infant Formula Composition on Gut Health in Infants: A Prospective Randomized Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07242508
- Acronym / sponsor ID
- ECCT2831
- Conditions
- Healthy Infants
- Keywords
- infant, formula, microbiota, gut health, RCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- FrieslandCampinaIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 19 Aug 2027 (estimated)
- Study completion
- 19 Aug 2027 (estimated)
- First posted
- 21 Nov 2025 (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 aim of this study is to investigate potential health benefits of the experimental formula. The main objective is whether the experimental formula elevates the relative abundance of Bifidobacterium in stool samples after 10 weeks, as compared a standard formula, aka control formula. In addition other markers of gut health, such as stool characteristics, and gut health symptoms will be monitored
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 |
|---|---|---|
| Experimental infant formula | Experimental | Other: Infant Formula with bioactive ingredientsInfant formula with bioactive ingredients |
| Control formula | Placebo comparator | Other: Infant FormulaStandard infant formula |
Who may qualify
- Ages
- 0 to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy, full term, infants with a birth weight between 2500-4500 grams
- Parents independently from study decided to not breastfeed their infant
- Parents agree to feed the assigned study formula as the infant's sole source of nutrition for the duration of the study
- have read and voluntarily signed an informed consent form
- parents are capable of completing study procedures required by the protocol
Key exclusion criteria (8 listed)
- suffering from any anatomic and/or physiologic condition that would interfere with normal growth, development or feeding
- are required to take medications or supplements known to influence growth and development
- have a maternal history with known adverse effects on the fetus and/or the newborn infant
- have previous or current antibiotics use (antibiotics administered during delivery are permitted)
- have received or are planning to receive probiotics, prebiotics, or nutritional supplements prior to and throughout the trial (excluding vitamin D and vitamin K supplementation)
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 Formulaad-libitum consumption of infant formula | Other | Control formula |
| Infant Formula with bioactive ingredientsad-libitum consumption | Other | Experimental infant formula |
Primary outcome
Bifidobacterium
Time frame: From enrollment to the end of treatment at 10 weeks
Relative abundance of bifidobacterium from stool samples
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 3 Sep 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.
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 and Infant Formula with bioactive ingredients in people with Healthy Infants, run by FrieslandCampina at 1 site in Bulgaria.
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 5 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: looking for participants now, as of the sponsor's last update on 3 Sep 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 Bulgaria. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bifidobacterium (time frame: From enrollment to the end of treatment at 10 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 3 Sep 2026.