Safety, Tolerability and Preliminary Efficacy of Lenodiar Pediatric in Diarrhea

NCT03598010 | Unknown

• 1 other identifier: ABO-LEN-02/19
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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

Conditions

Diarrhea; Chronic Diarrhea; Acute Diarrhea; Diarrhea, Infantile

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Day0 to Day28

Secondary Outcomes (10)

• Number of episodes of daily watery evacuations

  Day0-Day28

• Number of unformed stools passed per 24-h interval, after the first dose

  Day0-Day28

• Number of treatment failures

  Day0-Day28

• Difference in body weight

  Day0-Day28

• Frequency and severity of diarrhea associated symptoms

  Day0-Day28

Study Arms (2)

Lenodiar Pediatric in Acute/Prolonged Diarrhea

EXPERIMENTAL

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)

Lenodiar Pediatric in Chronic Diarrhea

EXPERIMENTAL

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)

Interventions

Actitan-F (7dd) DEVICE

1 sack every 4 hours, maximum 4 sacks/day for 7 days.

Lenodiar Pediatric in Acute/Prolonged Diarrhea

Actitan-F (28dd) DEVICE

1 sack every 4 hours, maximum 4 sacks/day for 28 days.

Lenodiar Pediatric in Chronic Diarrhea

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of either sex aged between 1-12 years (inclusive);
• 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;
• Evidence of mild to moderate dehydration, defined as a score 1-4 in the Clinical Dehydration Scale;
• Parents/legal guardians availability to fill on a daily basis the electronic daily diary by a smartphone/tablet/laptop.
• 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;
• 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.

You may not qualify if:

• Children of female sex having started menarche;
• Evidence of severe dehydration, defined as a score \> 4 in the Clinical Dehydration Scale;
• Known hypersensitivity to any of the components (active ingredients or excipients) of the investigational product;
• Severely malnourished patients, defined as those patients with body weight \< 50% for age;
• History of immune diseases or conditions known to producing immunodeficiency (AIDS, other congenital immunodeficiency syndromes, anticancer drugs, etc.);
• 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
• History of seizures due to known or unknown causes;
• Parents/legal guardians' refusal or inability to give written informed consent to participate in the study;
• Parents/legal guardians who, in the opinion of the Investigator, are unable to fill up the electronic patient diary;
• Patients who may not be possible to come for the scheduled visits;

Sponsors & Collaborators

• Aboca Spa Societa' Agricola: lead

MeSH Terms

Conditions

Diarrhea; Diarrhea, Infantile

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Niccolò Ravenni, PhD

CONTACT

+39 0575 746; clinicaltrials@aboca.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 26, 2018
• Study Start: October 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: June 4, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share