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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07207109 on ClinicalTrials.gov