An Evaluation of the Tolerability and Acceptability of a New Plant-based Formula for Young Children
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Yogyakarta, Indonesia, 55281
- Universitas Gadjah Mada
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Other: Plant based formula for young children
The study is designed with a single arm, so all subjects will receive the study product.
|
Daily intake of plant based formula for 3 weeks (400ml-600ml per day).
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stool characteristics - Stool frequency
Time Frame: Baseline
|
Average stool frequency, derived from daily records in the diary
|
Baseline
|
|
Stool characteristics - Stool frequency
Time Frame: Day 1- 7
|
Average stool frequency, derived from daily records in the diary
|
Day 1- 7
|
|
Stool characteristics - Stool frequency
Time Frame: Day 8- 14
|
Average stool frequency, derived from daily records in the diary
|
Day 8- 14
|
|
Stool characteristics - Stool frequency
Time Frame: Day 15- 21
|
Average stool frequency, derived from daily records in the diary
|
Day 15- 21
|
|
Stool characteristics - Stool consistency
Time Frame: Baseline
|
Average stool consistency, derived from daily records in the diary
|
Baseline
|
|
Stool characteristics - Stool consistency
Time Frame: Day 1-7
|
Average stool consistency, derived from daily records in the diary
|
Day 1-7
|
|
Stool characteristics - Stool consistency
Time Frame: Day 8-14
|
Average stool consistency, derived from daily records in the diary
|
Day 8-14
|
|
Stool characteristics - Stool consistency
Time Frame: Day 15-21
|
Average stool consistency, derived from daily records in the diary
|
Day 15-21
|
|
Stool characteristics - Occurrence of frequent watery stools
Time Frame: Baseline
|
Number of watery stools, derived from daily records in the diary
|
Baseline
|
|
Stool characteristics - Occurrence of frequent watery stools
Time Frame: Day 1-7
|
Number of watery stools, derived from daily records in the diary
|
Day 1-7
|
|
Stool characteristics - Occurrence of frequent watery stools
Time Frame: Day 8-14
|
Number of watery stools, derived from daily records in the diary
|
Day 8-14
|
|
Stool characteristics - Occurrence of frequent watery stools
Time Frame: Day 15-21
|
Number of watery stools, derived from daily records in the diary
|
Day 15-21
|
|
Stool characteristics - Occurrence of hard stools
Time Frame: Baseline
|
Number of hard stools, derived from daily records in the diary
|
Baseline
|
|
Stool characteristics - Occurrence of hard stools
Time Frame: Day 1-7
|
Number of hard stools, derived from daily records in the diary
|
Day 1-7
|
|
Stool characteristics - Occurrence of hard stools
Time Frame: Day 8-14
|
Number of hard stools, derived from daily records in the diary
|
Day 8-14
|
|
Stool characteristics - Occurrence of hard stools
Time Frame: Day 15-21
|
Number of hard stools, derived from daily records in the diary
|
Day 15-21
|
|
Gastrointestinal symptoms
Time Frame: Baseline
|
Occurrence of vomiting [present/absent], derived from records in the diary
|
Baseline
|
|
Gastrointestinal symptoms
Time Frame: Day 1-7
|
Occurrence of vomiting [present/absent], derived from records in the diary
|
Day 1-7
|
|
Gastrointestinal symptoms
Time Frame: Day 8-14
|
Occurrence of vomiting [present/absent], derived from records in the diary
|
Day 8-14
|
|
Gastrointestinal symptoms
Time Frame: Day 15-21
|
Occurrence of vomiting [present/absent], derived from records in the diary
|
Day 15-21
|
|
Flatulence
Time Frame: Baseline
|
Occurrence of flatulence [present/absent], derived from records in the diary
|
Baseline
|
|
Flatulence
Time Frame: Day 1-7
|
Occurrence of flatulence [present/absent], derived from records in the diary
|
Day 1-7
|
|
Flatulence
Time Frame: Day 8-14
|
Occurrence of flatulence [present/absent], derived from records in the diary
|
Day 8-14
|
|
Flatulence
Time Frame: Day 15-21
|
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
Time Frame: Baseline
|
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
Time Frame: Day 1-7
|
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
Time Frame: Day 8-14
|
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
Time Frame: Day 15-21
|
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
Time Frame: Baseline
|
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
Time Frame: Day 1-7
|
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
Time Frame: Day 8-14
|
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
Time Frame: Day 15-21
|
Scored as per five-point Likert scale for each of the questions to parents.
|
Day 15-21
|
|
Product acceptability
Time Frame: Baseline
|
Scored as per five-point Danone developed questionnaire ( 1= low satisfaction 5 = high satisfaction) for each of the questions to parents.
|
Baseline
|
|
Product acceptability
Time Frame: Day 1-7
|
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
Time Frame: Day 8-14
|
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
Time Frame: Day 15-21
|
Scored as per five-point Danone developed questionnaire ( 1= low satisfaction 5 = high satisfaction) for each of the questions to parents.
|
Day 15-21
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- SBB20R&31559
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Young Children
-
NCT06924307RecruitingCognitive Intervention to Promote Healthy Development of Executive Function (EF) Skills in Young Children
-
NCT05441137RecruitingYoung Children With Motor Disabilities
-
NCT03707405CompletedYoung Children With Motor Disabilities
-
NCT06000631RecruitingYoung Children With Motor Disabilities
-
NCT03416595UnknownIntestinal Growth of Young Children
-
NCT01628978UnknownEndotracheal Intubation | Infants or Young Children
-
NCT06287697Active, not recruitingBody Composition | Energy Expenditure | Infant and Young Child Feeding | Infants and Young Children
-
NCT05718752CompletedHealthy Young Women | Healthy Young Men
-
NCT07213011CompletedHealthy Subjects | Healthy Participants | Health | Massage Effect | Healthy Young Adults | Myofascial Release | Stretching | Healthy Young People
Clinical Trials on Plant based formula for children aged between 12 and 36 months
-
NCT06567171CompletedPain | Parent | Hospital | Ethiopia
-
NCT07091474Not yet recruiting
-
NCT01569581CompletedThe Efficacy of Inactivated EV71 Vaccine (KMB17) Against HFMD in Chinese Children and Infants
-
NCT05983705CompletedQuality of Life | Stress | Parent-Child Relations | Parenting | Behavior, Child