Safety, Tolerability and Preliminary Efficacy of Lenodiar Pediatric in Diarrhea

NCT ID: NCT03598010

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2021-03-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Actitan-F (7dd)

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Actitan-F (28dd)

Intervention Type: DEVICE

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

Interventions

Actitan-F (7dd)

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

Intervention Type: DEVICE

Actitan-F (28dd)

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

Intervention Type: DEVICE

Eligibility 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

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aboca Spa Societa' Agricola

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Niccolò Ravenni, PhD

Role: CONTACT

clinicaltrials@aboca.it

+39 0575 746

Other Identifiers

ABO-LEN-02/19

Identifier Type: -

Identifier Source: org_study_id