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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
1 sack every 4 hours, maximum 4 sacks/day for 7 days.
1 sack every 4 hours, maximum 4 sacks/day for 28 days.
Acute (onset <7 days) or Prolonged Diarrhea (onset ≥7 and ≤14 days): Response Rate (RR) measured after 4 treatment days.
Acute (onset \<7 days) or Prolonged Diarrhea (onset ≥7 and \<14 days): Response Rate (RR) measured after 4 treatment days. Patients will be considered as responders if they have experienced the passage of 2 formed stools or no stool for at least 12 consecutive hours during the 4 days treatment.
Time frame: Day0 to Day4
Chronic Diarrhea (onset >14 days): Response Rate (RR) measured across the whole treatment period
Chronic Diarrhea (onset \>14 days): Response Rate (RR) measured across the whole treatment period (4 weeks). Patients will be considered as responders if they have experienced a 50% (or more) reduction in the number of days with at least 1 diarrheic stools (Bristol score 6 or 7) in the whole treatment period (4 weeks) compared to the 7 days prior the treatment (baseline).
Time frame: Day0 to Day28
Number of episodes of daily watery evacuations
Number of episodes of daily watery evacuations evaluated by means of the electronic patient diaries;
Time frame: Day0-Day28
Number of unformed stools passed per 24-h interval, after the first dose
Number of unformed stools passed per 24-h interval, after dosing evaluated by means of the electronic patient diaries
Time frame: Day0-Day28
Number of treatment failures
Number of treatment failures. A treatment failure is defined as clinical deterioration or worsening of symptoms or illness continuing after 120 h following the first dose evaluated by means of the electronic patient diaries
Time frame: Day0-Day28
Difference in body weight
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Difference in body weight between baseline and End of Treatment
Time frame: Day0-Day28
Frequency and severity of diarrhea associated symptoms
Frequency and severity of diarrhea associated symptoms (nausea, vomiting, abdominal pain). Severity will be evaluated by means of a 0-4 Likert scale (0 = none; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe);
Time frame: Day0-Day28
Treatment Compliance
Evaluation of the nr of sachets prescribed by the investigators and the % of compliance recorded
Time frame: Day0-Day28
Proportion of patients requiring other (allowed) treatments
Proportion of patients requiring other treatments in addition to Lenodiar Pediatric or to other concomitant treatments prescribed at baseline visit for diarrhea symptoms relief (e.g. parenteral rehydration and/or other medications) evaluated by means of the electronic patient diaries
Time frame: Day0-Day28
Change in results of the Pediatric Quality of Life Questionnaire (PedsQL)
Change in results of the Pediatric Quality of Life Questionnaire (PedsQL) between baseline and End of Treatment visits
Time frame: Day0-Day28
Change in results in parent assessment of children Quality of Life (100 mm VAS)
Change in results in parent assessment of children Quality of Life (100 mm VAS) between baseline and End of Treatment visits
Time frame: Day0-Day28
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;
Incidence of adverse events (AEs) and serious adverse events (SAEs), and rate of study discontinuations due to AEs/SAE;
Time frame: Day0-Day28