DiarrheaNCT03598010
Safety, Tolerability and Preliminary Efficacy of Lenodiar Pediatric in Diarrhea
A study testing Actitan-F (7dd) and Actitan-F (28dd) in people with Diarrhea and Chronic Diarrhea, run by Aboca Spa Societa' Agricola.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Diarrhea, Chronic Diarrhea, Acute Diarrhea
- What is being tested?
- Actitan-F (7dd) and Actitan-F (28dd)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 16Show fewer
- 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;
- Patients who have participated in any other clinical trial in the last 3 months prior to the start of the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety, Tolerability and Preliminary Efficacy of Oral Administration of Tannins and Flavonoids in the Management of Pediatric Diarrhea
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
- Being tested
- Actitan-F (7dd), Actitan-F (28dd)
- Medical subject headings
- Diarrhea, Diarrhea, Infantile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actitan-F (7dd)Device
1 sack every 4 hours, maximum 4 sacks/day for 7 days.
Actitan-F (28dd)Device
1 sack every 4 hours, maximum 4 sacks/day for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Actitan-F (28dd) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Day0 to Day28
Secondary outcomes (10)
Number of episodes of daily watery evacuations
Number of episodes of daily watery evacuations evaluated by means of the electronic patient diaries;
Measured: Day0-Day28
Number of unformed stools passed per 24-h interval, after the first dose
Number of unformed stools passed per 24-h interval, after dosing evaluated by means of the electronic patient diaries
Measured: Day0-Day28
Number of treatment failures
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
Measured: Day0-Day28
Difference in body weight
Difference in body weight between baseline and End of Treatment
Measured: Day0-Day28
Frequency and severity of diarrhea associated symptoms
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);
Measured: Day0-Day28
Treatment Compliance
Evaluation of the nr of sachets prescribed by the investigators and the % of compliance recorded
Measured: Day0-Day28
Proportion of patients requiring other (allowed) treatments
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
Measured: Day0-Day28
Change in results of the Pediatric Quality of Life Questionnaire (PedsQL)
Change in results of the Pediatric Quality of Life Questionnaire (PedsQL) between baseline and End of Treatment visits
Measured: Day0-Day28
Change in results in parent assessment of children Quality of Life (100 mm VAS)
Change in results in parent assessment of children Quality of Life (100 mm VAS) between baseline and End of Treatment visits
Measured: Day0-Day28
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;
Incidence of adverse events (AEs) and serious adverse events (SAEs), and rate of study discontinuations due to AEs/SAE;
Measured: Day0-Day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study startOct 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aboca Spa Societa' Agricola
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598010
- Sponsor's protocol ID
- ABO-LEN-02/19
- Status last verified
- May 2019
- First submitted
- 2 Jul 2018
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Preliminary Efficacy of Oral Administration of Tannins and Flavonoids in the Management of Pediatric Diarrhea
- ClinicalTrials.gov ID
- NCT03598010
- Acronym / sponsor ID
- ABO-LEN-02/19
- Conditions
- Diarrhea, Chronic Diarrhea, Acute Diarrhea, Diarrhea, Infantile
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Aboca Spa Societa' AgricolaIndustry (pharma, biotech, devices)
- Study start
- Oct 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lenodiar Pediatric in Acute/Prolonged Diarrhea | Experimental | Device: 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 | Experimental | Device: 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. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
- 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;
Key exclusion criteria (16 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actitan-F (7dd)1 sack every 4 hours, maximum 4 sacks/day for 7 days. | Device | Lenodiar Pediatric in Acute/Prolonged Diarrhea |
| Actitan-F (28dd)1 sack every 4 hours, maximum 4 sacks/day for 28 days. | Device | Lenodiar Pediatric in Chronic Diarrhea |
Primary outcome
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.
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).
10 secondary outcomes
Number of episodes of daily watery evacuations
Time frame: Day0-Day28
Number of unformed stools passed per 24-h interval, after the first dose
Time frame: Day0-Day28
Number of treatment failures
Time frame: Day0-Day28
Difference in body weight
Time frame: Day0-Day28
Frequency and severity of diarrhea associated symptoms
Time frame: Day0-Day28
Treatment Compliance
Time frame: Day0-Day28
Proportion of patients requiring other (allowed) treatments
Time frame: Day0-Day28
Change in results of the Pediatric Quality of Life Questionnaire (PedsQL)
Time frame: Day0-Day28
Change in results in parent assessment of children Quality of Life (100 mm VAS)
Time frame: Day0-Day28
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Actitan-F (7dd) and Actitan-F (28dd) in people with Diarrhea and Chronic Diarrhea, run by Aboca Spa Societa' Agricola.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Niccolò Ravenni, PhD (+39 0575 746, clinicaltrials@aboca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.