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TerminatedNCT05265156Updated May 20, 2022

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

An interventional study of Plant based formula for children aged between 12 and 36 months in Healthy Young Children, sponsored by Nutricia Research. Terminated at 1 site in Indonesia. Open to participants aged 1 Year to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-20.

Sponsored by Nutricia Research · Not applicable, Interventional, and Other

Why this study was terminated
High drop out rate
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
1 Year to 3 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy Young Children
03

In context

Lead sponsor

Nutricia Research is the lead sponsor of 48 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 3 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Other
    Plant based formula for young children

    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

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).

06

What researchers measure

Primary outcomes

  1. Stool characteristics - Stool frequency

    Average stool frequency, derived from daily records in the diary

    Time frame: Baseline

  2. Stool characteristics - Stool frequency

    Average stool frequency, derived from daily records in the diary

    Time frame: Day 1- 7

  3. Stool characteristics - Stool frequency

    Average stool frequency, derived from daily records in the diary

    Time frame: Day 8- 14

  4. Stool characteristics - Stool frequency

    Average stool frequency, derived from daily records in the diary

    Time frame: Day 15- 21

  5. Stool characteristics - Stool consistency

    Average stool consistency, derived from daily records in the diary

    Time frame: Baseline

  6. Stool characteristics - Stool consistency

    Average stool consistency, derived from daily records in the diary

    Time frame: Day 1-7

  7. Stool characteristics - Stool consistency

    Average stool consistency, derived from daily records in the diary

    Time frame: Day 8-14

  8. Stool characteristics - Stool consistency

    Average stool consistency, derived from daily records in the diary

    Time frame: Day 15-21

  9. Stool characteristics - Occurrence of frequent watery stools

    Number of watery stools, derived from daily records in the diary

    Time frame: Baseline

  10. Stool characteristics - Occurrence of frequent watery stools

    Number of watery stools, derived from daily records in the diary

    Time frame: Day 1-7

  11. Stool characteristics - Occurrence of frequent watery stools

    Number of watery stools, derived from daily records in the diary

    Time frame: Day 8-14

  12. Stool characteristics - Occurrence of frequent watery stools

    Number of watery stools, derived from daily records in the diary

    Time frame: Day 15-21

  13. Stool characteristics - Occurrence of hard stools

    Number of hard stools, derived from daily records in the diary

    Time frame: Baseline

  14. Stool characteristics - Occurrence of hard stools

    Number of hard stools, derived from daily records in the diary

    Time frame: Day 1-7

  15. Stool characteristics - Occurrence of hard stools

    Number of hard stools, derived from daily records in the diary

    Time frame: Day 8-14

  16. Stool characteristics - Occurrence of hard stools

    Number of hard stools, derived from daily records in the diary

    Time frame: Day 15-21

  17. Gastrointestinal symptoms

    Occurrence of vomiting \[present/absent\], derived from records in the diary

    Time frame: Baseline

  18. Gastrointestinal symptoms

    Occurrence of vomiting \[present/absent\], derived from records in the diary

    Time frame: Day 1-7

  19. Gastrointestinal symptoms

    Occurrence of vomiting \[present/absent\], derived from records in the diary

    Time frame: Day 8-14

  20. Gastrointestinal symptoms

    Occurrence of vomiting \[present/absent\], derived from records in the diary

    Time frame: Day 15-21

  21. Flatulence

    Occurrence of flatulence \[present/absent\], derived from records in the diary

    Time frame: Baseline

  22. Flatulence

    Occurrence of flatulence \[present/absent\], derived from records in the diary

    Time frame: Day 1-7

  23. Flatulence

    Occurrence of flatulence \[present/absent\], derived from records in the diary

    Time frame: Day 8-14

  24. Flatulence

    Occurrence of flatulence \[present/absent\], derived from records in the diary

    Time frame: Day 15-21

  25. 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

    Time frame: Baseline

  26. 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

    Time frame: Day 1-7

  27. 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

    Time frame: Day 8-14

  28. 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

    Time frame: Day 15-21

  29. 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.

    Time frame: Baseline

  30. 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.

    Time frame: Day 1-7

  31. 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.

    Time frame: Day 8-14

  32. Parents' observation and perception of child's wellbeing and stools

    Scored as per five-point Likert scale for each of the questions to parents.

    Time frame: Day 15-21

  33. Product acceptability

    Scored as per five-point Danone developed questionnaire ( 1= low satisfaction 5 = high satisfaction) for each of the questions to parents.

    Time frame: Baseline

  34. Product acceptability

    Scored as per five-point Danone developed questionnaire ( 1= low satisfaction 5 = high satisfaction) for each of the questions to parents..

    Time frame: Day 1-7

  35. Product acceptability

    Scored as per five-point Danone developed questionnaire ( 1= low satisfaction 5 = high satisfaction) for each of the questions to parents.

    Time frame: Day 8-14

  36. Product acceptability

    Scored as per five-point Danone developed questionnaire ( 1= low satisfaction 5 = high satisfaction) for each of the questions to parents.

    Time frame: Day 15-21

07

Study locations

1 site
  • Universitas Gadjah Mada
    Yogyakarta, 55281, Indonesia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05265156
Lead sponsor
Nutricia Research
Responsible party
Sponsor
First posted
Mar 3, 2022
Start date
Jan 7, 2022
Primary completion
Apr 14, 2022
Completion
Apr 14, 2022
Last update
May 20, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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