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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Test: Follow-on formula with synbiotics
Other interventionIntervention description: both products are nutritionally complete follow-on formulas
Control: Regular follow-on formula
Other interventionIntervention description: both products are nutritionally complete follow-on formulas
Treatment groups
268 Participants
are divided into 2 treatment groupsGroup A: test productExperimental treatment 1 intervention
Group B: control productActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Bifidobacteria proportions
The mean change from baseline in the proportion of faecal Bifidobacterium at 12 weeks postbaseline
Time frame
Baseline and 12 weeks postbaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nutricia Research
Lead sponsor
PT Nutricia Indonesia Sejahtera
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: