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

Nutricia Research26 enrolled

Overview

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

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Young Children

Interventions

Plant based formula for children aged between 12 and 36 monthsOTHER

Daily intake of plant based formula for 3 weeks (400ml-600ml per day).

Eligibility

Sex: ALLMin age: 1 YearMax age: 3 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Universitas Gadjah Mada

Yogyakarta, Indonesia

Outcomes

Primary Outcomes

Stool characteristics - Stool frequency

Average stool frequency, derived from daily records in the diary

Time frame: Baseline

Stool characteristics - Stool frequency

Average stool frequency, derived from daily records in the diary

Time frame: Day 1- 7

Stool characteristics - Stool frequency

Average stool frequency, derived from daily records in the diary

Time frame: Day 8- 14

Stool characteristics - Stool frequency

Average stool frequency, derived from daily records in the diary

Time frame: Day 15- 21

Stool characteristics - Stool consistency

Average stool consistency, derived from daily records in the diary

Time frame: Baseline

Stool characteristics - Stool consistency

Average stool consistency, derived from daily records in the diary

Time frame: Day 1-7

Stool characteristics - Stool consistency

Average stool consistency, derived from daily records in the diary

Time frame: Day 8-14

Stool characteristics - Stool consistency

Average stool consistency, derived from daily records in the diary

Time frame: Day 15-21

Stool characteristics - Occurrence of frequent watery stools

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

Data from ClinicalTrials.gov

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Time frame: Baseline

Stool characteristics - Occurrence of frequent watery stools

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

Time frame: Day 1-7

Stool characteristics - Occurrence of frequent watery stools

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

Time frame: Day 8-14

Stool characteristics - Occurrence of frequent watery stools

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

Time frame: Day 15-21

Stool characteristics - Occurrence of hard stools

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

Time frame: Baseline

Stool characteristics - Occurrence of hard stools

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

Time frame: Day 1-7

Stool characteristics - Occurrence of hard stools

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

Time frame: Day 8-14

Stool characteristics - Occurrence of hard stools

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

Time frame: Day 15-21

Gastrointestinal symptoms

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

Time frame: Baseline

Gastrointestinal symptoms

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

Time frame: Day 1-7

Gastrointestinal symptoms

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

Time frame: Day 8-14

Gastrointestinal symptoms

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

Time frame: Day 15-21

Flatulence

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

Time frame: Baseline

Flatulence

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

Time frame: Day 1-7

Flatulence

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

Time frame: Day 8-14

Flatulence

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Day 15-21

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