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NCT Number: NCT07207109

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

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Key information

Age range

6 month–9 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Test: Follow-on formula with synbiotics

Other

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

Control: Regular follow-on formula

Other

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

Primary outcomes

  1. Bifidobacteria proportions

    Time frame: Baseline and 12 weeks postbaseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Danone Global Research & Innovation Center

CONTACT

[email protected]

+31 30 2095 000

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

Collaborators

  • PT Nutricia Indonesia Sejahtera

Registry information

Official study 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.

Acronym: FUNTASTIC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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