NCT07207109

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Nov 2025

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Nov 2025Jun 2027

First Submitted

Initial submission to the registry

September 23, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
29 days until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

October 3, 2025

Status Verified

October 1, 2025

Enrollment Period

1.4 years

First QC Date

September 23, 2025

Last Update Submit

October 2, 2025

Conditions

Follow-on FormulaInfantFaecesGut Microbiota

Keywords

Follow-on formulahealthy infantsgut microbiota

Outcome Measures

Primary Outcomes (1)

  • Bifidobacteria proportions

    The mean change from baseline in the proportion of faecal Bifidobacterium at 12 weeks postbaseline

    Baseline and 12 weeks postbaseline

Study Arms (2)

test product

EXPERIMENTAL

Group that receives follow-on formula with synbiotics

Other: Test: Follow-on formula with synbiotics

control product

ACTIVE COMPARATOR

Group that receives regular follow-on formula

Other: Control: Regular follow-on formula

Interventions

Test: Follow-on formula with synbioticsOTHER

Intervention description: both products are nutritionally complete follow-on formulas

test product
Control: Regular follow-on formulaOTHER

Intervention description: both products are nutritionally complete follow-on formulas

control product

Eligibility Criteria

Age6 Months - 9 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Infants with known or suspected medical conditions requiring a special diet or special formulae, food allergy, or food intolerances
  • Infants who received breastfeeding ≤14 days before Visit 1
  • Infants who are potty-trained
  • 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.
  • 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.
  • Infants with previous, current, or intended participation in any other clinical study involving investigational or marketed products.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Denpasar, Bali, Indonesia

Location

SBY_RSUD Dr. Soetomo

Surabaya, East Java, Indonesia

Location

MeSH Terms

Interventions

Synbiotics

Intervention Hierarchy (Ancestors)

PrebioticsDietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaProbioticsFood and Beverages

Central Study Contacts

Danone Global Research & Innovation Center

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2025

First Posted

October 3, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

October 3, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

ID(2)