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

October 2, 2025 updated by: Nutricia Research

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

268

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
    • Bali
      • Denpasar, Bali, Indonesia
        • DPS_RSUP Prof. Dr. I.G.N.G. Ngoerah
        • Contact:
          • Dr. N.N.M Nesa, M.Sc., Sp. A(K)
          • Phone Number: +62 0361227911
    • East Java
      • Surabaya, East Java, Indonesia
        • SBY_RSUD Dr. Soetomo
        • Contact:
          • Dr. A. Dharma Sp.A(K) Ph.D
          • Phone Number: +62 0813-3233-3806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: test product
Group that receives follow-on formula with synbiotics
Other: Test: Follow-on formula with synbiotics
Intervention description: both products are nutritionally complete follow-on formulas
Active Comparator: control product
Group that receives regular follow-on formula
Other: Control: Regular follow-on formula
Intervention description: both products are nutritionally complete follow-on formulas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bifidobacteria proportions
Time Frame: Baseline and 12 weeks postbaseline
The mean change from baseline in the proportion of faecal Bifidobacterium at 12 weeks postbaseline
Baseline and 12 weeks postbaseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutricia Research

Collaborators

PT Nutricia Indonesia Sejahtera

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

September 23, 2025

First Submitted That Met QC Criteria

October 2, 2025

First Posted (Actual)

October 3, 2025

Study Record Updates

Last Update Posted (Actual)

October 3, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24REX0075490

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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