Diarrhea Clinical Trial
Official title:
RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF XILOGLUCAN IN ACUTE GASTROENTERITIS IN CHILDREN
Acute gastroenteritis (GEA) is an inflammation of the intestinal mucosa that clinically
translates into an acute episode of diarrhea and vomiting and is generally associated with an
intestinal infectious disease. It is one of the most common diseases in children and an
important cause of morbidity and mortality worldwide. The important loss of liquids can lead
to dehydration, acidosis and hydroelectrolitic alteration. Infants are more vulnerable to
gastrointestinal infection and its consequences, dehydration and malnutrition.
There is no specific treatment, so it is exclusively symptomatic
A new type of products considered as mucoprotectors has been developed, such as gelatin
tannate or xyloglucan, still with little data to establish recommendations on its use in the
GEA. They would be able to reproduce in the intestine a muco-adhesive film or sheet
protective It must be considered in this sense that mucus is the first barrier that protects
the gastrointestinal tract against microorganisms or antigens and that bacterial invasion is
related to the opening of narrow junctions.
Xyloglucan was approved in Europe as a medical device IIa to restore the physiological
functions of the intestinal wall in the form of capsules for adults and envelopes for
children.
A randomized, blinded study with a control group is proposed in this project to establish
solidly the efficacy of xyloglucan in the treatment of acute gastroenteritis in children.
The main variable of evaluation will be the duration of diarrhea, defined as the time it
takes to normalize the consistency of stools (according to the Bristol or Amsterdam scale) or
their number.
Clinical trial in phase IV with medical product type IIa and CE marking, used in the same
conditions in which it is marketed.
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