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

Not Applicable

Not yet recruiting

• Conditions: Follow-on Formula; Infant; Faeces; Gut Microbiota

• Registration Number: NCT07207109
• Lead Sponsor: Nutricia Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-09-23
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-02
• Last Update Submitted: 2025-10-02
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Study Start: 2025-11-01
• Primary Completion: 2027-04
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 268

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bifidobacteria proportions	Baseline and 12 weeks postbaseline	The mean change from baseline in the proportion of faecal Bifidobacterium at 12 weeks postbaseline

Trial Locations

Locations (2)

DPS_RSUP Prof. Dr. I.G.N.G. Ngoerah; 🇮🇩 Denpasar, Bali, Indonesia

SBY_RSUD Dr. Soetomo; 🇮🇩 Surabaya, East Java, Indonesia