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ClinicalTrials.gov ID

NCT07207109

Lead Sponsor

Nutricia ResearchINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

268Estimated

Last Update Posted

Oct 3, 2025Actual

Start Date

Nov 2025Estimated

Primary Completion Date

Apr 2027Estimated

Completion Date

Jun 2027Estimated

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.

Brief 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.

• Follow-on Formula
• Infant
• Faeces
• Gut Microbiota

• Test: Follow-on formula with synbiotics
• Control: Regular follow-on formula

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

1. Healthy infants as per the clinical judgement of the Investigator
2. Singleton infants
3. Infants ≥6 months and ≤9 months of age at Visit 1
4. Infant's weight-for-age WHO z-score within ± 2 SD at Visit 1
5. Infants fed with an infant or follow-on formula at Visit 1.
6. Infants are familiar with, and are expected to drink, ≥600 mL formula per day.
7. Written informed consent (IC) from parent(s) and/or legally acceptable representative(s) aged ≥18 years at Visit 1.

Exclusion Criteria:

1. Infants with known or suspected medical conditions requiring a special diet or special formulae, food allergy, or food intolerances
2. Infants who received breastfeeding ≤14 days before Visit 1
3. Infants who are potty-trained
4. 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.
5. Use of medication or nutritional products/food supplements known to impact the study outcomes ≤14 days before Visit 1 or expected need during the study.
6. Infants with previous, current, or intended participation in any other clinical study involving investigational or marketed products.
7. Incapability of infants' parents and/or legally acceptable representative(s) to comply with study protocol as per the judgement of the investigator or investigator's uncertainty about the willingness or ability of parents legally acceptable representative(s) to comply with the protocol requirements, including access to a phone.
8. Children of employees and/or family members or relatives of employees of Danone, the participating sites, or any other nutrition company that develops infant, follow-on or young child formulae.

Primary Purpose

Basic Science

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

Nutricia ResearchINDUSTRY

Collaborators

PT Nutricia Indonesia SejahteraUNKNOWN

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