Follow-on FormulaFUNTASTICNCT07207109
Effect of follow-on Formula on the Gut Microbiota of Healthy Infants.
A study testing Test: Follow-on formula with synbiotics in people with Follow-on Formula and Infant, run by Nutricia Research at 2 sites in Indonesia.
Trial summary
This study investigates the effects of follow-on formula in infants aged 6-9 months over a 12-week period. After parents give consent, their baby's feeding habits, stool characteristics, and any illnesses or medication use will be recorded. Read more about this study
- Who is it for?
- Ages 6 to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Follow-on Formula, Infant, Faeces
- What is being tested?
- Test: Follow-on formula with synbiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 2 sitesIndonesia
- Study dates
- 23 Dec 2025to 6 Nov 2026
- 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 6 to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants as per the clinical judgement of the Investigator
- Singleton infants
- Infants ≥6 months and ≤9 months of age at Visit 1
- Infant's weight-for-age WHO z-score within ± 2 SD at Visit 1
- Infants fed with an infant or follow-on formula at Visit 1.
- Infants are familiar with, and are expected to drink, ≥600 mL formula per day.
- Written informed consent (IC) from parent(s) and/or legally acceptable representative(s) aged ≥18 years at Visit 1.
Who cannot join
- Infants with known or suspected medical conditions requiring a special diet or special formulae, food allergy, or food intolerances
- Infants who received breastfeeding ≤14 days before Visit 1
- Infants who are potty-trained
- Infants with current or previous illnesses/conditions and/or known or suspected congenital diseases or malformations which could interfere with the study outcomes, as per investigator's clinical judgement.
- Use of medication or nutritional products/food supplements known to impact the study outcomes ≤14 days before Visit 1 or expected need during the study.
- Infants with previous, current, or intended participation in any other clinical study involving investigational or marketed products.
- Incapability of infants' parents and/or legally acceptable representative(s) to comply with study protocol as per the judgement of the investigator or investigator's uncertainty about the willingness or ability of parents legally acceptable representative(s) to comply with the protocol requirements, including access to a phone.
- Children of employees and/or family members or relatives of employees of Danone, the participating sites, or any other nutrition company that develops infant, follow-on or young child formulae.
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
DPS_RSUP Prof. Dr. I.G.N.G. Ngoerah
Denpasar, Bali
SBY_RSUD Dr. Soetomo
Surabaya, East Java
About this study
Official title: A Double-blind Randomised Controlled Study to Investigate the Effect of a follow-on Formula With a Specific Synbiotic Mixture on the Gut Microbiota Composition in Healthy Infants.
This study investigates the effects of follow-on formula in infants aged 6-9 months over a 12-week period. After parents give consent, their baby's feeding habits, stool characteristics, and any illnesses or medication use will be recorded. Infants will be randomly assigned to receive either the test or control product. Growth and health data will be collected during study visits.
Parents will collect stool samples and complete diaries to help researchers better understand the baby's digestion and overall health. A follow-up phone call will be made to check on the baby's well-being after the study ends.
- Conditions
- Follow-on Formula, Infant, Faeces, Gut Microbiota
- Being tested
- Test: Follow-on formula with synbiotics, Control: Regular follow-on formula
- Keywords
- Follow-on formula, healthy infants, gut microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test: Follow-on formula with synbioticsOther
Intervention description: both products are nutritionally complete follow-on formulas
Control: Regular follow-on formulaOther
Intervention description: both products are nutritionally complete follow-on formulas
| Study group | Role | What they receive |
|---|---|---|
| test product | Experimental | Group that receives follow-on formula with synbiotics Receives: Other: Test: Follow-on formula with synbiotics |
| control product | Active comparator | Group that receives regular follow-on formula Receives: Other: Control: Regular follow-on formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bifidobacteria proportions
The mean change from baseline in the proportion of faecal Bifidobacterium at 12 weeks postbaseline
Measured: Baseline and 12 weeks postbaseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start23 Dec 2025
- Primary completion6 Nov 2026 (estimated)
- Study completion6 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follow-on FormulaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PT Nutricia Indonesia Sejahtera
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207109
- Sponsor's protocol ID
- 24REX0075490
- Acronym
- FUNTASTIC
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2025
- Last updated
- 8 Oct 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomised Controlled Study to Investigate the Effect of a follow-on Formula With a Specific Synbiotic Mixture on the Gut Microbiota Composition in Healthy Infants.
- ClinicalTrials.gov ID
- NCT07207109
- Acronym / sponsor ID
- FUNTASTIC / 24REX0075490
- Conditions
- Follow-on Formula, Infant, Faeces, Gut Microbiota
- Keywords
- Follow-on formula, healthy infants, gut microbiota
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Collaborators
- PT Nutricia Indonesia Sejahtera
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- 6 Nov 2026 (estimated)
- Study completion
- 6 Nov 2026 (estimated)
- First posted
- 3 Oct 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.
This study investigates the effects of follow-on formula in infants aged 6-9 months over a 12-week period. After parents give consent, their baby's feeding habits, stool characteristics, and any illnesses or medication use will be recorded. Infants will be randomly assigned to receive either the test or control product. Growth and health data will be collected during study visits.
Parents will collect stool samples and complete diaries to help researchers better understand the baby's digestion and overall health. A follow-up phone call will be made to check on the baby's well-being after the study ends.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test product | Experimental | Other: Test: Follow-on formula with synbioticsGroup that receives follow-on formula with synbiotics |
| control product | Active comparator | Other: Control: Regular follow-on formulaGroup that receives regular follow-on formula |
Who may qualify
- Ages
- 6 to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy infants as per the clinical judgement of the Investigator
- Singleton infants
- Infants ≥6 months and ≤9 months of age at Visit 1
- Infant's weight-for-age WHO z-score within ± 2 SD at Visit 1
- Infants fed with an infant or follow-on formula at Visit 1.
Key exclusion criteria (8 listed)
- Infants with known or suspected medical conditions requiring a special diet or special formulae, food allergy, or food intolerances
- Infants who received breastfeeding ≤14 days before Visit 1
- Infants who are potty-trained
- Infants with current or previous illnesses/conditions and/or known or suspected congenital diseases or malformations which could interfere with the study outcomes, as per investigator's clinical judgement.
- Use of medication or nutritional products/food supplements known to impact the study outcomes ≤14 days before Visit 1 or expected need during the study.
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 |
|---|---|---|
| Test: Follow-on formula with synbioticsIntervention description: both products are nutritionally complete follow-on formulas | Other | test product |
| Control: Regular follow-on formulaIntervention description: both products are nutritionally complete follow-on formulas | Other | control product |
Primary outcome
Bifidobacteria proportions
Time frame: Baseline and 12 weeks postbaseline
The mean change from baseline in the proportion of faecal Bifidobacterium at 12 weeks postbaseline
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 8 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Follow-on Formula
Enrolling by invitation
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Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants
Active, not recruiting
Effects of an Infant Formula and follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections
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CLINICAL INVESTIGATION TO EVALUATE THE EFFICACY AND SAFETY OF EPILADY PROTOTYPE DEVICE FOLLOWED BY APPLICATION OF A TOPICAL FORMULA ON DEPIGMENTATION OF LENTIGO SPOTS
Solar Lentigo
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test: Follow-on formula with synbiotics in people with Follow-on Formula and Infant, run by Nutricia Research at 2 sites in Indonesia.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. 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?
Bifidobacteria proportions (time frame: Baseline and 12 weeks postbaseline). 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 8 Oct 2026.