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

Nutricia

Status: Not yet enrolling

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

Treatments: Other: Control: Regular follow-on formula; Other: Test: Follow-on formula with synbiotics

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07207109

24REX0075490

Details and patient eligibility

About

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.

Enrollment: 268 estimated patients

Sex: All

Ages: 6 to 9 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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268 participants in 2 patient groups

test product

Experimental group

Description:

Group that receives follow-on formula with synbiotics

Treatment:

Other: Test: Follow-on formula with synbiotics

control product

Active Comparator group

Description:

Group that receives regular follow-on formula

Treatment:

Other: Control: Regular follow-on formula