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Effect of follow-on Formula on the Gut Microbiota of Healthy Infants. | Clinical Trials | Clareo Health

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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.

NCT07207109•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.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (2)

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

Denpasar, Bali, Indonesia

SBY_RSUD Dr. Soetomo

Surabaya, East Java, Indonesia

Key Dates

Start Date

November 1, 2025

Primary Completion Date

April 1, 2027

Completion Date

June 1, 2027

Last Updated

October 3, 2025

Enrollment

268

ESTIMATED participants

Conditions

Follow-on FormulaInfantFaecesGut Microbiota

Interventions

Test: Follow-on formula with synbiotics

OTHER

Control: Regular follow-on formula

OTHER

Contacts

Danone Global Research & Innovation Center

CONTACT

+31 30 2095 000 register.clinicalresearchnutricia@danone.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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