Effect of follow-on Formula on the Gut Microbiota of Healthy Infants.
NCT07207109 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 268
Last updated 2025-10-03
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. 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
Interventions
- OTHER
-
Test: Follow-on formula with synbiotics
Intervention description: both products are nutritionally complete follow-on formulas
- OTHER
-
Control: Regular follow-on formula
Intervention description: both products are nutritionally complete follow-on formulas
Sponsors & Collaborators
-
PT Nutricia Indonesia Sejahtera
collaborator UNKNOWN -
Nutricia Research
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 9 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-11-30
- Primary Completion
- 2027-04-30
- Completion
- 2027-06-30
Countries
- Indonesia
Study Locations
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