An Evaluation of the Tolerability and Acceptability of a New Plant-based Formula for Young Children

Nutricia

Status: Terminated

Conditions: Healthy Young Children

Treatments: Other: Plant based formula for children aged between 12 and 36 months

Study type: Interventional

Funder types: Industry

Identifiers

NCT05265156

SBB20R&31559

Details and patient eligibility

About

An evaluation of the tolerability and acceptability of a new plant-based formula in 45 healthy young children

Full description

The aim of this study is to evaluate the tolerability and acceptability of a new plant-based formula for young children. The study population consists of 45 healthy children of ≥12 and <36 months of age

Enrollment: 26 patients

Sex: All

Ages: 1 to 3 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male and female children as per the clinical judgement of the Investigator
2. Singleton children
3. Children ≥12 and <36 months of age at screening
4. Children who have been drinking dairy based beverages or plant-based milk replacements (in combination with breastfeeding or not) for at least 3 weeks prior to screening
5. Children are familiar with drinking ≥400 ml/day of dairy based beverages or plant-based milk replacements,
6. Written informed consent from the parent(s) and/or legal guardian(s) (≥ 18 years of age)

Exclusion criteria

1. Children with medical conditions requiring a special diet such as fibre-free diet, food allergy, or food intolerances
2. Children with current or previous illnesses/conditions or interventions which could interfere with the study or its outcome parameters (e.g. diarrhoea requiring treatment, constipation requiring treatment, regurgitation requiring treatment, dental/medical procedures which may impact oral feeding), as per the clinical judgment of the Investigator, within 3 weeks prior to screening
3. Use of medication or nutritional/food supplements known to impact GI tolerance (e.g. anti-regurgitation (including any thickening agent), anti-reflux, anti-diarrheal, laxative medication, systemic antibiotic, probiotic supplements) within 3 weeks prior to screening
4. Children who are using diapers
5. Siblings of participating children
6. Participation in any other study involving investigational or marketed products concomitantly or within 3 weeks prior to screening
7. Children of employees and/or family members or relatives of employees of Danone Nutricia Indonesia or of the participating research institute and local community facilities
8. Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol instructions, including daily completion of the diaries by the parents.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Plant based formula for young children

Other group

Description:

The study is designed with a single arm, so all subjects will receive the study product.

Treatment:

Other: Plant based formula for children aged between 12 and 36 months