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

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

Study Overview

• Status: Terminated
• Conditions: Healthy Young Children
• Intervention / Treatment: Other: Plant based formula for children aged between 12 and 36 months

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Yogyakarta, Indonesia, 55281
    • Universitas Gadjah Mada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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.

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

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Daily intake of plant based formula for 3 weeks (400ml-600ml per day).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nutricia Research

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2022
• Primary Completion (Actual): April 14, 2022
• Study Completion (Actual): April 14, 2022

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: SBB20R&31559

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No