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Not yet recruiting NCT07207109

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

No phase Interventional Follow-on Formula Infant Faeces Gut Microbiota

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Test: Follow-on formula with synbiotics, Control: Regular follow-on formula.
Who it may be relevant to
Registry conditions: Follow-on Formula, Infant, Faeces, Gut Microbiota. Basic parameters: 6 months — 9 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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.

Overview

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.

Interventions

  • Other Test: Follow-on formula with synbiotics
    Intervention description: both products are nutritionally complete follow-on formulas
  • Other Control: Regular follow-on formula
    Intervention description: both products are nutritionally complete follow-on formulas

Primary outcome measures

  • Bifidobacteria proportions [Time frame: Baseline and 12 weeks postbaseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

Indonesia · 2 centers
  • DPS_RSUP Prof. Dr. I.G.N.G. Ngoerah — Denpasar
  • SBY_RSUD Dr. Soetomo — Surabaya

Identifiers

NCT: NCT07207109 · 24REX0075490

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗