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

Not Applicable

Terminated

• Conditions: Healthy Young Children
• Interventions: Other: Plant based formula for children aged between 12 and 36 months

• Registration Number: NCT05265156
• Lead Sponsor: Nutricia Research

Brief Summary

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 Timeline

• Study First Submitted: 2021-12-16
• Study Start: 2022-01-07
• Study First Submitted QC: 2022-02-22
• Study First Posted: 2022-03-03
• Primary Completion: 2022-04-14
• Study Completion: 2022-04-14
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Plant based formula for young children	Plant based formula for children aged between 12 and 36 months	The study is designed with a single arm, so all subjects will receive the study product.

Primary Outcome Measures

Name	Time	Method
Stool characteristics - Stool frequency	Day 15- 21	Average stool frequency, derived from daily records in the diary
Stool characteristics - Occurrence of hard stools	Day 15-21	Number of hard stools, derived from daily records in the diary
Gastrointestinal symptoms	Day 15-21	Occurrence of vomiting \[present/absent\], derived from records in the diary
Flatulence	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	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
Stool characteristics - Stool consistency	Day 15-21	Average stool consistency, derived from daily records in the diary
Product acceptability	Day 15-21	Scored as per five-point Danone developed questionnaire ( 1= low satisfaction 5 = high satisfaction) for each of the questions to parents.
Stool characteristics - Occurrence of frequent watery stools	Day 15-21	Number of watery stools, derived from daily records in the diary
Parents' observation and perception of child's wellbeing and stools	Day 15-21	Scored as per five-point Likert scale for each of the questions to parents.

Trial Locations

Locations (1)

Universitas Gadjah Mada; 🇮🇩 Yogyakarta, Indonesia