Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Tolerability and Preliminary Efficacy of Lenodiar Pediatric in Diarrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03598010
Recruitment Status : Not yet recruiting
First Posted : July 25, 2018
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Diarrhea Chronic Diarrhea Acute Diarrhea Diarrhea, Infantile Device: Actitan-F (7dd) Device: Actitan-F (28dd) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Preliminary Efficacy of Oral Administration of Tannins and Flavonoids in the Management of Pediatric Diarrhea
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: Lenodiar Pediatric in Acute/Prolonged Diarrhea

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.
Device: Actitan-F (7dd)
1 sack every 4 hours, maximum 4 sacks/day for 7 days.

Experimental: Lenodiar Pediatric in Chronic Diarrhea

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.
Device: Actitan-F (28dd)
1 sack every 4 hours, maximum 4 sacks/day for 28 days.




Primary Outcome Measures :
  1. Acute (onset <7 days) or Prolonged Diarrhea (onset ≥7 and ≤14 days): Response Rate (RR) measured after 4 treatment days. [ Time Frame: 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.

  2. Chronic Diarrhea (onset >14 days): Response Rate (RR) measured across the whole treatment period [ Time Frame: 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 :
  1. Number of episodes of daily watery evacuations [ Time Frame: Day0-Day28 ]
    Number of episodes of daily watery evacuations evaluated by means of the electronic patient diaries;

  2. Number of unformed stools passed per 24-h interval, after the first dose [ Time Frame: Day0-Day28 ]
    Number of unformed stools passed per 24-h interval, after dosing evaluated by means of the electronic patient diaries

  3. Number of treatment failures [ Time Frame: 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

  4. Difference in body weight [ Time Frame: Day0-Day28 ]
    Difference in body weight between baseline and End of Treatment

  5. Frequency and severity of diarrhea associated symptoms [ Time Frame: 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);

  6. Treatment Compliance [ Time Frame: Day0-Day28 ]
    Evaluation of the nr of sachets prescribed by the investigators and the % of compliance recorded

  7. Proportion of patients requiring other (allowed) treatments [ Time Frame: 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

  8. Change in results of the Pediatric Quality of Life Questionnaire (PedsQL) [ Time Frame: Day0-Day28 ]
    Change in results of the Pediatric Quality of Life Questionnaire (PedsQL) between baseline and End of Treatment visits

  9. Change in results in parent assessment of children Quality of Life (100 mm VAS) [ Time Frame: Day0-Day28 ]
    Change in results in parent assessment of children Quality of Life (100 mm VAS) between baseline and End of Treatment visits

  10. 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; [ Time Frame: Day0-Day28 ]
    Incidence of adverse events (AEs) and serious adverse events (SAEs), and rate of study discontinuations due to AEs/SAE;



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598010


Contacts
Layout table for location contacts
Contact: Niccolò Ravenni, PhD +39 0575 746 clinicaltrials@aboca.it

Sponsors and Collaborators
Aboca Spa Societa' Agricola

Layout table for additonal information
Responsible Party: Aboca Spa Societa' Agricola
ClinicalTrials.gov Identifier: NCT03598010     History of Changes
Other Study ID Numbers: ABO-LEN-02/19
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Diarrhea
Diarrhea, Infantile
Signs and Symptoms, Digestive
Signs and Symptoms