Healthy Young Children
Conditions
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 age
Interventions
OTHERPlant based formula for children aged between 12 and 36 months
Daily intake of plant based formula for 3 weeks (400ml-600ml per day).
Sponsors
Nutricia Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single arm, prospective, open-label, longitudinal, interventional study
Eligibility
Sex/Gender
ALL
Age
1 Years to 3 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stool characteristics - Stool frequency | Baseline | Average stool frequency, derived from daily records in the diary |
| Stool characteristics - Stool consistency | Baseline | Average stool consistency, derived from daily records in the diary |
| Stool characteristics - Occurrence of frequent watery stools | Baseline | Number of watery stools, derived from daily records in the diary |
| Stool characteristics - Occurrence of hard stools | Baseline | Number of hard stools, derived from daily records in the diary |
| Gastrointestinal symptoms | Baseline | Occurrence of vomiting \[present/absent\], derived from records in the diary |
| Flatulence | Baseline | Occurrence of flatulence \[present/absent\], derived from records in the diary |
| Proportion of parents [number / percentage] consulting a health care professional related to medical events linked to gastrointestinal tolerance | Baseline | Occurrence of parents consulting a health care professional related to medical events linked to gastrointestinal tolerance, derived from records in the diary |
| Parents' observation and perception of child's wellbeing and stools | Baseline | Scored as per five-point Danone developed questionnaire ( 1= low satisfaction 5 = high satisfaction) for each of the questions to parents. |
| Product acceptability | Baseline | Scored as per five-point Danone developed questionnaire ( 1= low satisfaction 5 = high satisfaction) for each of the questions to parents. |
Countries
Indonesia
Outcome results
None listed