Status:
TERMINATED
An Evaluation of the Tolerability and Acceptability of a New Plant-based Formula for Young Children
Lead Sponsor:
Nutricia Research
Conditions:
Healthy Young Children
Eligibility:
All Genders
1-3 years
Phase:
NA
Brief Summary
An evaluation of the tolerability and acceptability of a new plant-based formula in 45 healthy young children
Detailed 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 ...
Eligibility Criteria
Inclusion
- Healthy male and female children as per the clinical judgement of the Investigator
- Singleton children
- Children ≥12 and \<36 months of age at screening
- 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
- Children are familiar with drinking ≥400 ml/day of dairy based beverages or plant-based milk replacements,
- Written informed consent from the parent(s) and/or legal guardian(s) (≥ 18 years of age)
Exclusion
- Children with medical conditions requiring a special diet such as fibre-free diet, food allergy, or food intolerances
- 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
- 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
- Children who are using diapers
- Siblings of participating children
- Participation in any other study involving investigational or marketed products concomitantly or within 3 weeks prior to screening
- 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
- 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.
Key Trial Info
Start Date :
January 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05265156
Start Date
January 7 2022
End Date
April 14 2022
Last Update
May 20 2022
Active Locations (1)
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1
Universitas Gadjah Mada
Yogyakarta, Indonesia, 55281