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

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

Detailed Description
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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

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

Conditions
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Healthy Young Children

Intervention / Treatment
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* Other: Plant based formula for children aged between 12 and 36 months


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm, prospective, open-label, longitudinal, interventional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Plant based formula for young children<br>The study is designed with a single arm, so all subjects will receive the study product. | Other: Plant based formula for children aged between 12 and 36 months<br>* Daily intake of plant based formula for 3 weeks (400ml-600ml per day).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool characteristics - Stool frequency | Average stool frequency, derived from daily records in the diary | Baseline | 
| Stool characteristics - Stool frequency | Average stool frequency, derived from daily records in the diary | Day 1- 7 | 
| Stool characteristics - Stool frequency | Average stool frequency, derived from daily records in the diary | Day 8- 14 | 
| Stool characteristics - Stool frequency | Average stool frequency, derived from daily records in the diary | Day 15- 21 | 
| Stool characteristics - Stool consistency | Average stool consistency, derived from daily records in the diary | Baseline | 
| Stool characteristics - Stool consistency | Average stool consistency, derived from daily records in the diary | Day 1-7 | 
| Stool characteristics - Stool consistency | Average stool consistency, derived from daily records in the diary | Day 8-14 | 
| Stool characteristics - Stool consistency | Average stool consistency, derived from daily records in the diary | Day 15-21 | 
| Stool characteristics - Occurrence of frequent watery stools | Number of watery stools, derived from daily records in the diary | Baseline | 
| Stool characteristics - Occurrence of frequent watery stools | Number of watery stools, derived from daily records in the diary | Day 1-7 | 
| Stool characteristics - Occurrence of frequent watery stools | Number of watery stools, derived from daily records in the diary | Day 8-14 | 
| Stool characteristics - Occurrence of frequent watery stools | Number of watery stools, derived from daily records in the diary | Day 15-21 | 
| Stool characteristics - Occurrence of hard stools | Number of hard stools, derived from daily records in the diary | Baseline | 
| Stool characteristics - Occurrence of hard stools | Number of hard stools, derived from daily records in the diary | Day 1-7 | 
| Stool characteristics - Occurrence of hard stools | Number of hard stools, derived from daily records in the diary | Day 8-14 | 
| Stool characteristics - Occurrence of hard stools | Number of hard stools, derived from daily records in the diary | Day 15-21 | 
| Gastrointestinal symptoms | Occurrence of vomiting [present/absent], derived from records in the diary | Baseline | 
| Gastrointestinal symptoms | Occurrence of vomiting [present/absent], derived from records in the diary | Day 1-7 | 
| Gastrointestinal symptoms | Occurrence of vomiting [present/absent], derived from records in the diary | Day 8-14 | 
| Gastrointestinal symptoms | Occurrence of vomiting [present/absent], derived from records in the diary | Day 15-21 | 
| Flatulence | Occurrence of flatulence [present/absent], derived from records in the diary | Baseline | 
| Flatulence | Occurrence of flatulence [present/absent], derived from records in the diary | Day 1-7 | 
| Flatulence | Occurrence of flatulence [present/absent], derived from records in the diary | Day 8-14 | 
| Flatulence | Occurrence of flatulence [present/absent], derived from records in the diary | Day 15-21 | 
| Proportion of parents [number / percentage] consulting a health care professional related to medical events linked to gastrointestinal tolerance | Occurrence of parents consulting a health care professional related to medical events linked to gastrointestinal tolerance, derived from records in the diary | Baseline | 
| Proportion of parents [number / percentage] consulting a health care professional related to medical events linked to gastrointestinal tolerance | Occurrence of parents consulting a health care professional related to medical events linked to gastrointestinal tolerance, derived from records in the diary | Day 1-7 | 
| Proportion of parents [number / percentage] consulting a health care professional related to medical events linked to gastrointestinal tolerance | Occurrence of parents consulting a health care professional related to medical events linked to gastrointestinal tolerance, derived from records in the diary | Day 8-14 | 
| Proportion of parents [number / percentage] consulting a health care professional related to medical events linked to gastrointestinal tolerance | Occurrence of parents consulting a health care professional related to medical events linked to gastrointestinal tolerance, derived from records in the diary | Day 15-21 | 
| Parents' observation and perception of child's wellbeing and stools | Scored as per five-point Danone developed questionnaire ( 1= low satisfaction 5 = high satisfaction) for each of the questions to parents. | Baseline | 
| Parents' observation and perception of child's wellbeing and stools | Scored as per five-point Danone developed questionnaire ( 1= low satisfaction 5 = high satisfaction) for each of the questions to parents. | Day 1-7 | 
| Parents' observation and perception of child's wellbeing and stools | Scored as per five-point Danone developed questionnaire ( 1= low satisfaction 5 = high satisfaction) for each of the questions to parents. | Day 8-14 | 
| Parents' observation and perception of child's wellbeing and stools | Scored as per five-point Likert scale for each of the questions to parents. | Day 15-21 | 
| Product acceptability | Scored as per five-point Danone developed questionnaire ( 1= low satisfaction 5 = high satisfaction) for each of the questions to parents. | Baseline | 
| Product acceptability | Scored as per five-point Danone developed questionnaire ( 1= low satisfaction 5 = high satisfaction) for each of the questions to parents.. | Day 1-7 | 
| Product acceptability | Scored as per five-point Danone developed questionnaire ( 1= low satisfaction 5 = high satisfaction) for each of the questions to parents. | Day 8-14 | 
| Product acceptability | Scored as per five-point Danone developed questionnaire ( 1= low satisfaction 5 = high satisfaction) for each of the questions to parents. | Day 15-21 |