UnknownNot Applicable

Safety, Tolerability and Preliminary Efficacy of Lenodiar Pediatric in Diarrhea

240 participantsStarted 2019-10

Plain-language 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

Who can participate

Age range

1 Year – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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;
. 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

. Children of female sex having started menarche;
. Evidence of severe dehydration, defined as a score \> 4 in the Clinical Dehydration Scale;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acute (onset <7 days) or Prolonged Diarrhea (onset ≥7 and ≤14 days): Response Rate (RR) measured after 4 treatment days.

Timeframe: Day0 to Day4

Chronic Diarrhea (onset >14 days): Response Rate (RR) measured across the whole treatment period

Timeframe: Day0 to Day28

Trial details

NCT IDNCT03598010

SponsorAboca Spa Societa' Agricola

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12

Contact for this trial

Niccolò Ravenni, PhD

+39 0575 746 clinicaltrials@aboca.it

View on ClinicalTrials.gov More Diarrhea trials