Status:
NOT_YET_RECRUITING
Effect of follow-on Formula on the Gut Microbiota of Healthy Infants.
Lead Sponsor:
Nutricia Research
Collaborating Sponsors:
PT Nutricia Indonesia Sejahtera
Conditions:
Follow-on Formula
Infant
Eligibility:
All Genders
6-9 years
Phase:
NA
Brief 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 illne...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT07207109
Start Date
November 1 2025
End Date
June 1 2027
Last Update
October 3 2025
Active Locations (2)
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1
DPS_RSUP Prof. Dr. I.G.N.G. Ngoerah
Denpasar, Bali, Indonesia
2
SBY_RSUD Dr. Soetomo
Surabaya, East Java, Indonesia