Safety, Tolerability and Preliminary Efficacy of Lenodiar Pediatric in Diarrhea
Safety, Tolerability and Preliminary Efficacy of Lenodiar Pediatric in Diarrhea
Evaluation of the efficacy of a treatment with Actitan-F, a natural molecular complex of
 tannins (from Agrimony and Tormentil) and flavonoids (Chamomile) in a pediatric population of
 children affected by acture/prolonged/chronic diarrhea
Inclusion Criteria

 1. Children of either sex aged between 1-12 years (inclusive);

 2. Evidence of acute (onset <7 days prior to screening visit), prolonged (onset between 7
 and 14 days prior to screening visit) or chronic (onset >14 days prior to screening
 visit) diarrhea.

 -  Acute/Prolonged Diarrhea is defined as at least 3 evacuations of loose or watery
 stools (stools type 6-7 of Bristol scale) occurring in the 24 hours preceding the
 screening visit.

 -  Chronic Diarrhea (>14 days duration), defined by passage of loose or watery
 stools (Bristol score 6 or 7) with or without an increase in frequency of bowel
 movements;

 3. Evidence of mild to moderate dehydration, defined as a score 1-4 in the Clinical
 Dehydration Scale;

 4. Parents/legal guardians availability to fill on a daily basis the electronic daily
 diary by a smartphone/tablet/laptop.

 5. Parents/legal guardians* have given a written informed consent for participation in
 the study at the time of enrolment or before. The parent/legal guardian should also
 have agreed to bring the child for the visits scheduled in the protocol and to provide
 the requested information during the telephonic follow-up visit;

 6. Parents/legal guardian able to understand the full nature and the purpose of the
 investigation, including possible risks and side effects, able to cooperate with the
 Investigator and to comply with the requirements of the entire investigation (ability
 to attend all the planned investigation visits according to the time limits included)
 based on Investigator's judgement.

 Exclusion Criteria:

 Exclusion Criteria

 1. Children of female sex having started menarche;

 2. Evidence of severe dehydration, defined as a score > 4 in the Clinical Dehydration
 Scale;

 3. Known hypersensitivity to any of the components (active ingredients or excipients) of
 the investigational product;

 4. Severely malnourished patients, defined as those patients with body weight < 50% for
 age;

 5. History of immune diseases or conditions known to producing immunodeficiency (AIDS,
 other congenital immunodeficiency syndromes, anticancer drugs, etc.);

 6. For acute/prolonged diarrhea only, patients who have received any of the following
 treatments within the 2 weeks before the screening/baseline visit:

 -  Drugs with adsorbing properties, e.g. kaolin, pectin, bismuth subsalicylate;

 -  Drugs that modify intestinal secretions, e.g. racecadotril;

 -  Drugs that modify intestinal motility, e.g. opiates such as loperamide, atropine
 and other anti-cholinergic agents);

 -  Laxatives

 -  Antibiotics

 7. History of seizures due to known or unknown causes;

 8. Parents/legal guardians' refusal or inability to give written informed consent to
 participate in the study;

 9. Parents/legal guardians who, in the opinion of the Investigator, are unable to fill up
 the electronic patient diary;

 10. Patients who may not be possible to come for the scheduled visits;

 11. Patients who have participated in any other clinical trial in the last 3 months prior
 to the start of the study.