Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02016703
• Date of registration: 16/12/2013
• Prospective Registration: No
• Primary sponsor: Cargill
• Public title: Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children
• Scientific title: Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children
• Date of first enrolment: March 2006
• Target sample size: 185
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02016703
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Evelyne Jacqz-Aigrain, PhD
• Affiliation: Clinical Investigation Centre Robert Debré Hospital, Paris, France

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy

- Age 4 to 6 years at Study D1 (day of consumption of the first beverage)

- Body Mass Index ³ 13 kg/m²

- Accustomed to having breakfast

- Having a regular defecation frequency inferior or equal to two per day

- Able to drink 250 mL within 15 minutes

- Toilet-trained / able to use a potty (both at day and night)

- Informed consent of both person entitled to parental rights

- Person entitled to parental rights affiliated to the French social security

Exclusion Criteria:

- Participation in any clinical trial including blood sampling and/or administration of
substances up to 90 days before D1 of the study

- Participation in any non-invasive clinical trial up to 30 days before D1 of this
study, including blood sampling and/ or, intravenous, inhalatory administration of
substances

- Having a history of medical or surgical events that may significantly affect the study
outcome, such as gastric and digestive diseases

- Any current metabolic or endocrine disease, including diabetes mellitus

- Use of medication, including antibiotics, laxatives and steroids

- Regular gastrointestinal complaints, such as stomach upsets, diarrhoea, constipation,
flatulence, abdominal colic



Age minimum: 4 Years
Age maximum: 6 Years
Gender: All

Health Condition(s) or Problem(s) studied

Gastrointestinal

Tolerance

Intervention(s)

Other: Placebo drink

Other: Erythritol drink

Primary Outcome(s)

Diarrhoea and/or significant gastrointestinal (GI) symptoms [Time Frame: 48 hours]

Secondary Outcome(s)

Urinary erythritol excretion [Time Frame: 24 hours]

Gastrointestinal symptoms [Time Frame: 24 hours]

Stool frequency [Time Frame: 48 hours]

Stool consistency [Time Frame: 48 hours]

Secondary ID(s)

CER-TDEOH05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Biofortis Mérieux NutriSciences