NCT07207109

Effect of follow-on Formula on the Gut Microbiota of Healthy Infants.

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 268 (estimated)
• Sponsor: Nutricia Research · Industry
• Sex: All
• Age: 6 Months – 9 Months
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-11-01
• Primary completion: 2027-04-01
• Completion: 2027-06-01
• First posted: 2025-10-03
• Last updated: 2025-10-03

Locations

2 sites across 1 country: Indonesia