Effect of follow-on Formula on the Gut Microbiota of Healthy Infants.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-9
SponsorNutricia Research
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Test: Follow-on formula with synbiotics
- Control: Regular follow-on formula
Treatment groups
268 Participants
are divided into 2 treatment groupsSponsors and collaborators
Nutricia Research
Lead sponsor
PT Nutricia Indonesia Sejahtera
Collaborator
Source ClinicalTrials.gov