Signs and Symptoms, Digestive Clinical Trial
Official title:
Fiber Tolerability In Children Aged 3-7 Year
Determination of the digestive tolerability of the PROMITOR® in children from 3 to 7 years old.
The aim of the trial is to determine, using a dose escalation design, the digestive
tolerability of the PROMITOR®given at the doses of 6, then 9 and finally 12 g (corresponding
to 4, 6, and 8 g of fibers respectively) twice a day with the meals of the morning and of
the evening versus control (maltodextrin, no fiber) over one week of intake in children from
3 to 7 years old.
As it is an exploratory study there is no categorization between primary and secondary
objectives.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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