Healthy Young ChildrenNCT05265156
An Evaluation of the Tolerability and Acceptability of a New Plant-based Formula for Young Children
A study testing Plant based formula for children aged between 12 and 36 months in people with Healthy Young Children, run by Nutricia Research at 1 site in Indonesia.
Trial summary
An evaluation of the tolerability and acceptability of a new plant-based formula in 45 healthy young children Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Children
- What is being tested?
- Plant based formula for children aged between 12 and 36 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIndonesia
- Study dates
- 7 Jan 2022to 14 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
An evaluation of the tolerability and acceptability of a new plant-based formula in 45 healthy young children
Read the 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
- Conditions
- Healthy Young Children
- Being tested
- Plant based formula for children aged between 12 and 36 months
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant based formula for children aged between 12 and 36 monthsOther
Daily intake of plant based formula for 3 weeks (400ml-600ml per day).
| Study group | Role | What they receive |
|---|---|---|
| Plant based formula for young children | Other | The study is designed with a single arm, so all subjects will receive the study product. Receives: Other: Plant based formula for children aged between 12 and 36 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool characteristics - Stool frequency
Average stool frequency, derived from daily records in the diary
Measured: Baseline
Stool characteristics - Stool frequency
Average stool frequency, derived from daily records in the diary
Measured: Day 1- 7
Stool characteristics - Stool frequency
Average stool frequency, derived from daily records in the diary
Measured: Day 8- 14
Stool characteristics - Stool frequency
Average stool frequency, derived from daily records in the diary
Measured: Day 15- 21
Stool characteristics - Stool consistency
Average stool consistency, derived from daily records in the diary
Measured: Baseline
Stool characteristics - Stool consistency
Average stool consistency, derived from daily records in the diary
Measured: Day 1-7
Stool characteristics - Stool consistency
Average stool consistency, derived from daily records in the diary
Measured: Day 8-14
Stool characteristics - Stool consistency
Average stool consistency, derived from daily records in the diary
Measured: Day 15-21
Stool characteristics - Occurrence of frequent watery stools
Number of watery stools, derived from daily records in the diary
Measured: Baseline
Stool characteristics - Occurrence of frequent watery stools
Number of watery stools, derived from daily records in the diary
Measured: Day 1-7
Stool characteristics - Occurrence of frequent watery stools
Number of watery stools, derived from daily records in the diary
Measured: Day 8-14
Stool characteristics - Occurrence of frequent watery stools
Number of watery stools, derived from daily records in the diary
Measured: Day 15-21
Stool characteristics - Occurrence of hard stools
Number of hard stools, derived from daily records in the diary
Measured: Baseline
Stool characteristics - Occurrence of hard stools
Number of hard stools, derived from daily records in the diary
Measured: Day 1-7
Stool characteristics - Occurrence of hard stools
Number of hard stools, derived from daily records in the diary
Measured: Day 8-14
Stool characteristics - Occurrence of hard stools
Number of hard stools, derived from daily records in the diary
Measured: Day 15-21
Gastrointestinal symptoms
Occurrence of vomiting [present/absent], derived from records in the diary
Measured: Baseline
Gastrointestinal symptoms
Occurrence of vomiting [present/absent], derived from records in the diary
Measured: Day 1-7
Gastrointestinal symptoms
Occurrence of vomiting [present/absent], derived from records in the diary
Measured: Day 8-14
Gastrointestinal symptoms
Occurrence of vomiting [present/absent], derived from records in the diary
Measured: Day 15-21
Flatulence
Occurrence of flatulence [present/absent], derived from records in the diary
Measured: Baseline
Flatulence
Occurrence of flatulence [present/absent], derived from records in the diary
Measured: Day 1-7
Flatulence
Occurrence of flatulence [present/absent], derived from records in the diary
Measured: Day 8-14
Flatulence
Occurrence of flatulence [present/absent], derived from records in the diary
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Product acceptability
Scored as per five-point Danone developed questionnaire ( 1= low satisfaction 5 = high satisfaction) for each of the questions to parents..
Measured: 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.
Measured: 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.
Measured: Day 15-21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start7 Jan 2022
- Primary completion14 Apr 2022
- Study completion14 Apr 2022
Why it stopped: High drop out rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Young ChildrenStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, prospective, open-label, longitudinal, interventional study
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265156
- Sponsor's protocol ID
- SBB20R&31559
- Status last verified
- May 2022
- First submitted
- 16 Dec 2021
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Tolerability and Acceptability of a New Plant-based Formula for Young Children
- ClinicalTrials.gov ID
- NCT05265156
- Acronym / sponsor ID
- SBB20R&31559
- Conditions
- Healthy Young Children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: High drop out rate
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 14 Apr 2022 (actual)
- Study completion
- 14 Apr 2022 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, prospective, open-label, longitudinal, interventional study
| Arm | Type | Receives |
|---|---|---|
| Plant based formula for young children | Other | Other: Plant based formula for children aged between 12 and 36 monthsThe study is designed with a single arm, so all subjects will receive the study product. |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant based formula for children aged between 12 and 36 monthsDaily intake of plant based formula for 3 weeks (400ml-600ml per day). | Other | Plant based formula for young children |
Primary outcome
Stool characteristics - Stool frequency
Time frame: Baseline
Average stool frequency, derived from daily records in the diary
Stool characteristics - Stool frequency
Time frame: Day 1- 7
Average stool frequency, derived from daily records in the diary
Stool characteristics - Stool frequency
Time frame: Day 8- 14
Average stool frequency, derived from daily records in the diary
Stool characteristics - Stool frequency
Time frame: Day 15- 21
Average stool frequency, derived from daily records in the diary
Stool characteristics - Stool consistency
Time frame: Baseline
Average stool consistency, derived from daily records in the diary
Stool characteristics - Stool consistency
Time frame: Day 1-7
Average stool consistency, derived from daily records in the diary
Stool characteristics - Stool consistency
Time frame: Day 8-14
Average stool consistency, derived from daily records in the diary
Stool characteristics - Stool consistency
Time frame: Day 15-21
Average stool consistency, derived from daily records in the diary
Stool characteristics - Occurrence of frequent watery stools
Time frame: Baseline
Number of watery stools, derived from daily records in the diary
Stool characteristics - Occurrence of frequent watery stools
Time frame: Day 1-7
Number of watery stools, derived from daily records in the diary
Stool characteristics - Occurrence of frequent watery stools
Time frame: Day 8-14
Number of watery stools, derived from daily records in the diary
Stool characteristics - Occurrence of frequent watery stools
Time frame: Day 15-21
Number of watery stools, derived from daily records in the diary
Stool characteristics - Occurrence of hard stools
Time frame: Baseline
Number of hard stools, derived from daily records in the diary
Stool characteristics - Occurrence of hard stools
Time frame: Day 1-7
Number of hard stools, derived from daily records in the diary
Stool characteristics - Occurrence of hard stools
Time frame: Day 8-14
Number of hard stools, derived from daily records in the diary
Stool characteristics - Occurrence of hard stools
Time frame: Day 15-21
Number of hard stools, derived from daily records in the diary
Gastrointestinal symptoms
Time frame: Baseline
Occurrence of vomiting [present/absent], derived from records in the diary
Gastrointestinal symptoms
Time frame: Day 1-7
Occurrence of vomiting [present/absent], derived from records in the diary
Gastrointestinal symptoms
Time frame: Day 8-14
Occurrence of vomiting [present/absent], derived from records in the diary
Gastrointestinal symptoms
Time frame: Day 15-21
Occurrence of vomiting [present/absent], derived from records in the diary
Flatulence
Time frame: Baseline
Occurrence of flatulence [present/absent], derived from records in the diary
Flatulence
Time frame: Day 1-7
Occurrence of flatulence [present/absent], derived from records in the diary
Flatulence
Time frame: Day 8-14
Occurrence of flatulence [present/absent], derived from records in the diary
Flatulence
Time frame: Day 15-21
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
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
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
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
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
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.
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.
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.
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.
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.
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..
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.
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.
Results and safety
The study was stopped early (reason given: High drop out rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant based formula for children aged between 12 and 36 months in people with Healthy Young Children, run by Nutricia Research at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: High drop out rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool characteristics - Stool frequency (time frame: Baseline). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.