Acute Diarrhea, Chronic Diarrhea, Diarrhea, Diarrhea, Infantile
Conditions
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
Interventions
DEVICEActitan-F (7dd)
1 sack every 4 hours, maximum 4 sacks/day for 7 days.
DEVICEActitan-F (28dd)
1 sack every 4 hours, maximum 4 sacks/day for 28 days.
Sponsors
Aboca Spa Societa' Agricola
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute (onset <7 days) or Prolonged Diarrhea (onset ≥7 and ≤14 days): Response Rate (RR) measured after 4 treatment days. | Day0 to Day4 | 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. |
| Chronic Diarrhea (onset >14 days): Response Rate (RR) measured across the whole treatment period | Day0 to Day28 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment failures | Day0-Day28 | 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 |
| Difference in body weight | Day0-Day28 | Difference in body weight between baseline and End of Treatment |
| Frequency and severity of diarrhea associated symptoms | Day0-Day28 | 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); |
| Treatment Compliance | Day0-Day28 | Evaluation of the nr of sachets prescribed by the investigators and the % of compliance recorded |
| Number of episodes of daily watery evacuations | Day0-Day28 | Number of episodes of daily watery evacuations evaluated by means of the electronic patient diaries; |
| Change in results of the Pediatric Quality of Life Questionnaire (PedsQL) | Day0-Day28 | Change in results of the Pediatric Quality of Life Questionnaire (PedsQL) between baseline and End of Treatment visits |
| Change in results in parent assessment of children Quality of Life (100 mm VAS) | Day0-Day28 | Change in results in parent assessment of children Quality of Life (100 mm VAS) between baseline and End of Treatment visits |
| 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; | Day0-Day28 | Incidence of adverse events (AEs) and serious adverse events (SAEs), and rate of study discontinuations due to AEs/SAE; |
| Proportion of patients requiring other (allowed) treatments | Day0-Day28 | 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 |
| Number of unformed stools passed per 24-h interval, after the first dose | Day0-Day28 | Number of unformed stools passed per 24-h interval, after dosing evaluated by means of the electronic patient diaries |
Contacts
Primary ContactNiccolò Ravenni, PhD
Outcome results
None listed