Clinical TrialID 5839
Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children
NCT02016703
Gastrointestinal|Tolerance
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5839
- Evidence Id
- 5839
- Core Evidence Id
- 5839
- Source Clinical Trial Id
- 5823
- Herb2 Clinical Trial Id
- HBCT005823
- Nct Id
- NCT02016703
- Title
- Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children
- Status
- Completed
- Phase
- Study Result
- No
- Study Condition
- Gastrointestinal|Tolerance
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
- Intervention
- OTHER: Erythritol drink|OTHER: Placebo drink
- Intervention Allocation
- Randomized
- Intervention Model
- Crossover
- Intervention Mask
- Quadruple
- Intervention Purpose
- Supportive_Care
- Gender
- All
- Age
- Child
- Enrollment
- 185
- Outcome Measure
- Diarrhoea and/or significant gastrointestinal (GI) symptoms, Diarrhoea = a single watery stool (Bristol Stool Scale Score of 7) and/or \>3 faeces (regardless of consistency) in a 24 h period. Significant GI symptoms = any GI symptoms having a severity recorded as "severe intensity" in the symptom diary, 48 hours
- Sponsor Collaborator
- Cargill|Biofortis Mérieux NutriSciences
- Funded By
- INDUSTRY
- Location
- Clinical Investigation Centre Louis Pradel Hospital, Bron, 69677, France|Biofortis Merieux NutriSciences, Nantes, 44800, France|Clinical Investigation Centre Robert Debré Hospital, Paris, 75935, France
- Other Id
- CER-TDEOH05
- Start Date
- 2006-03
- Primary Completion Date
- 2009-07
- Completion Date
- 2010-07
- First Posted
- 2013-12-20
- Results First Posted
- Last Update Posted
- 2017-07-19
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT02016703
- Title Cn
- Title En
- Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children
- Bilingual Status
- semi_complete