Clinical trial NCT05265156: An Evaluation of the Tolerability and Acceptability of a New Plant-based Formula for Young Children
Official title: An Evaluation of the Tolerability and Acceptability of a New Plant-based Formula for Young Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy Young Children
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2022-03-03
Enrollment: 26
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm, prospective, open-label, longitudinal, interventional study
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: Stool characteristics - Stool frequency
timeFrame: Baseline
measure: Stool characteristics - Stool frequency
timeFrame: Day 1- 7
measure: Stool characteristics - Stool frequency
timeFrame: Day 8- 14
measure: Stool characteristics - Stool frequency
timeFrame: Day 15- 21
measure: Stool characteristics - Stool consistency
timeFrame: Baseline
measure: Stool characteristics - Stool consistency
timeFrame: Day 1-7
measure: Stool characteristics - Stool consistency
timeFrame: Day 8-14
measure: Stool characteristics - Stool consistency
timeFrame: Day 15-21
measure: Stool characteristics - Occurrence of frequent watery stools
timeFrame: Baseline
measure: Stool characteristics - Occurrence of frequent watery stools
timeFrame: Day 1-7
measure: Stool characteristics - Occurrence of frequent watery stools
timeFrame: Day 8-14
measure: Stool characteristics - Occurrence of frequent watery stools
timeFrame: Day 15-21
measure: Stool characteristics - Occurrence of hard stools
timeFrame: Baseline
measure: Stool characteristics - Occurrence of hard stools
timeFrame: Day 1-7
measure: Stool characteristics - Occurrence of hard stools
timeFrame: Day 8-14
measure: Stool characteristics - Occurrence of hard stools
timeFrame: Day 15-21
measure: Gastrointestinal symptoms
timeFrame: Baseline
measure: Gastrointestinal symptoms
timeFrame: Day 1-7
measure: Gastrointestinal symptoms
timeFrame: Day 8-14
measure: Gastrointestinal symptoms
timeFrame: Day 15-21
measure: Flatulence
timeFrame: Baseline
measure: Flatulence
timeFrame: Day 1-7
measure: Flatulence
timeFrame: Day 8-14
measure: Flatulence
timeFrame: Day 15-21
measure: Proportion of parents [number / percentage] consulting a health care professional related to medical events linked to gastrointestinal tolerance
timeFrame: Baseline
measure: Proportion of parents [number / percentage] consulting a health care professional related to medical events linked to gastrointestinal tolerance
timeFrame: Day 1-7
measure: Proportion of parents [number / percentage] consulting a health care professional related to medical events linked to gastrointestinal tolerance
timeFrame: Day 8-14
measure: Proportion of parents [number / percentage] consulting a health care professional related to medical events linked to gastrointestinal tolerance
timeFrame: Day 15-21
measure: Parents' observation and perception of child's wellbeing and stools
timeFrame: Baseline
measure: Parents' observation and perception of child's wellbeing and stools
timeFrame: Day 1-7
measure: Parents' observation and perception of child's wellbeing and stools
timeFrame: Day 8-14
measure: Parents' observation and perception of child's wellbeing and stools
timeFrame: Day 15-21
measure: Product acceptability
timeFrame: Baseline
measure: Product acceptability
timeFrame: Day 1-7
measure: Product acceptability
timeFrame: Day 8-14
measure: Product acceptability
timeFrame: Day 15-21
Secondary outcomes:
Other outcomes:
Locations:
city: Yogyakarta
country: Indonesia
facility: Universitas Gadjah Mada
Study officials:
References: