Oral Administration of Actitan-F in Paediatric Diarrhoea (NCT05904938) | Clinical Trial Compass
UnknownNot Applicable
Oral Administration of Actitan-F in Paediatric Diarrhoea
Italy136 participantsStarted 2023-07-10
Plain-language summary
The goal of the study is to investigate the efficacy and safety of Lenodiar Pediatric (product under investigation) for the treatment of Chronic Diarrhoea (functional or post-infective diarrhoea) in children aged 1-5 years old, through a randomized, double blind, placebo-controlled clinical investigation
Who can participate
Age range1 Year – 5 Years
SexALL
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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 1-5 years (inclusive);
* Diagnosis of chronic diarrhoea due to the following conditions:
* Functional gastrointestinal disorder fulfilling Rome IV Criteria\*
* or
* Functional gastrointestinal disorder fulfilling modified Rome IV Criteria \*\*
* or
* Post-infectious diarrea with daily painless, recurrent passage of three or more large, unformed stools
* Parents/legal guardians\*\*\* availability to fill on a daily basis the electronic daily diary by a smartphone/tablet.
* Parents/legal guardians have given a written informed consent for participation in the investigation 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;
* Willingness not to make diet and lifestyle significant changes during the trial.
* Rome IV criteria of functional diarrhoea (Neonate and Toddlers below 5 years), must include all of the following:
* Daily painless, recurrent passage of four …
What they're measuring
1
Change from baseline in stool consistency averaged over the 2-week Treatment Period