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NOT YET RECRUITING
NCT07207109
NA

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

Sponsor: Nutricia Research

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

6 Months - 9 Months

Study Type

INTERVENTIONAL

Enrollment

268

Start Date

2025-11

Completion Date

2027-06

Last Updated

2025-10-03

Healthy Volunteers

Yes

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

Locations (2)

DPS_RSUP Prof. Dr. I.G.N.G. Ngoerah

Denpasar, Bali, Indonesia

SBY_RSUD Dr. Soetomo

Surabaya, East Java, Indonesia