Safety, Tolerability and Preliminary Efficacy of Lenodiar Pediatric in Diarrhea

Not Applicable

• Conditions: Diarrhea; Chronic Diarrhea; Acute Diarrhea; Diarrhea, Infantile
• Interventions: Device: Actitan-F (7dd); Device: Actitan-F (28dd)

• Registration Number: NCT03598010
• Lead Sponsor: Aboca Spa Societa' Agricola

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-02
• Study First Submitted QC: 2018-07-23
• Study First Posted: 2018-07-26
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-31
• Last Update Posted: 2019-06-04
• Study Start: 2019-10
• Primary Completion: 2020-12
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lenodiar Pediatric in Acute/Prolonged Diarrhea	Actitan-F (7dd)	LenoDiar Pediatric acts thanks to Actitan-F, a plant-based molecular complex resulting from Aboca research which reduces attacks of diarrhoea and normalises the consistency of stools, helping to rapidly restore a balanced intestinal function. Actitan-F counteracts the inflammation of the intestinal mucous membrane, always present in the case of diarrhoea, through two action mechanisms: * a protective action, achieved by forming a barrier-effect film to limit contact with microorganisms and irritants; * an antioxidant action on the free radicals which counteracts the irritation of the mucous membrane.
Lenodiar Pediatric in Chronic Diarrhea	Actitan-F (28dd)	LenoDiar Pediatric acts thanks to Actitan-F, a plant-based molecular complex resulting from Aboca research which reduces attacks of diarrhoea and normalises the consistency of stools, helping to rapidly restore a balanced intestinal function. Actitan-F counteracts the inflammation of the intestinal mucous membrane, always present in the case of diarrhoea, through two action mechanisms: * a protective action, achieved by forming a barrier-effect film to limit contact with microorganisms and irritants; * an antioxidant action on the free radicals which counteracts the irritation of the mucous membrane.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of episodes of daily watery evacuations	Day0-Day28	Number of episodes of daily watery evacuations 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
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
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
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
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
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;