Clinical trial NCT03598010: Safety, Tolerability and Preliminary Efficacy of Lenodiar Pediatric in Diarrhea
Official title: Safety, Tolerability and Preliminary Efficacy of Oral Administration of Tannins and Flavonoids in the Management of Pediatric Diarrhea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diarrhea
Chronic Diarrhea
Acute Diarrhea
Diarrhea, Infantile
Lead sponsor: Aboca Spa Societa' Agricola
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 240
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Acute (onset <7 days) or Prolonged Diarrhea (onset ≥7 and ≤14 days): Response Rate (RR) measured after 4 treatment days.
timeFrame: Day0 to Day4
measure: Chronic Diarrhea (onset >14 days): Response Rate (RR) measured across the whole treatment period
timeFrame: Day0 to Day28
Secondary outcomes:
measure: Number of episodes of daily watery evacuations
timeFrame: Day0-Day28
measure: Number of unformed stools passed per 24-h interval, after the first dose
timeFrame: Day0-Day28
measure: Number of treatment failures
timeFrame: Day0-Day28
measure: Difference in body weight
timeFrame: Day0-Day28
measure: Frequency and severity of diarrhea associated symptoms
timeFrame: Day0-Day28
measure: Treatment Compliance
timeFrame: Day0-Day28
measure: Proportion of patients requiring other (allowed) treatments
timeFrame: Day0-Day28
measure: Change in results of the Pediatric Quality of Life Questionnaire (PedsQL)
timeFrame: Day0-Day28
measure: Change in results in parent assessment of children Quality of Life (100 mm VAS)
timeFrame: Day0-Day28
measure: Safety and tolerability of the treatment: Incidence of adverse events (AEs) and serious adverse events (SAEs), and rate of study discontinuations due to AEs/SAE;
timeFrame: Day0-Day28
Other outcomes:
Locations:
Study officials:
References: