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High drop out rate
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An evaluation of the tolerability and acceptability of a new plant-based formula in 45 healthy young children
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant based formula for young children | Other | The study is designed with a single arm, so all subjects will receive the study product. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant based formula for children aged between 12 and 36 months | Other | Daily intake of plant based formula for 3 weeks (400ml-600ml per day). |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Gadjah Mada | Yogyakarta | 55281 | Indonesia |
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Single arm, prospective, open-label, longitudinal, interventional study
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| 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 |