UnknownNot Applicable

Safety, Tolerability and Preliminary Efficacy of Lenodiar Pediatric in Diarrhea

240 participantsStarted 2019-10

Plain-language summary

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

Who can participate

Age range1 Year – 12 Years

SexALL

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Inclusion criteria

✓. Children of either sex aged between 1-12 years (inclusive);
✓. 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.
✓. Evidence of mild to moderate dehydration, defined as a score 1-4 in the Clinical Dehydration Scale;
✓. Parents/legal guardians availability to fill on a daily basis the electronic daily diary by a smartphone/tablet/laptop.
✓. 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;
✓. 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

✕. Children of female sex having started menarche;
✕. Evidence of severe dehydration, defined as a score \> 4 in the Clinical Dehydration Scale;
✕. Known hypersensitivity to any of the components (active ingredients or excipients) of the investigational product;
✕. Severely malnourished patients, defined as those patients with body weight \< 50% for age;
✕. History of immune diseases or conditions known to producing immunodeficiency (AIDS, other congenital immunodeficiency syndromes, anticancer drugs, etc.);
✕. For acute/prolonged diarrhea only, patients who have received any of the following treatments within the 2 weeks before the screening/baseline visit:
✕. History of seizures due to known or unknown causes;
✕. Parents/legal guardians' refusal or inability to give written informed consent to participate in the study;

What they're measuring

Acute (onset <7 days) or Prolonged Diarrhea (onset ≥7 and ≤14 days): Response Rate (RR) measured after 4 treatment days.

Timeframe: Day0 to Day4

Chronic Diarrhea (onset >14 days): Response Rate (RR) measured across the whole treatment period

Timeframe: Day0 to Day28

Trial details

NCT IDNCT03598010

SponsorAboca Spa Societa' Agricola

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12

Contact for this trial

Niccolò Ravenni, PhD

+39 0575 746 clinicaltrials@aboca.it

View on ClinicalTrials.gov More Diarrhea trials