Oral Administration of Actitan-F in Paediatric Diarrhoea

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 morelarge, unformed stools
• Parents/legal guardians*** availability to fill on a daily basis the electronic dailydiary by a smartphone/tablet.
• Parents/legal guardians have given a written informed consent for participation in theinvestigation at the time of enrolment or before. The parent/legal guardian shouldalso have agreed to bring the child for the visits scheduled in the protocol and toprovide the requested information during the telephonic follow-up visit;
• Parents/legal guardian able to understand the full nature and the purpose of theinvestigation, including possible risks and side effects, able to cooperate with theInvestigator and to comply with the requirements of the entire investigation (abilityto 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 or more large, unformed stools
• Symptoms last more than 4 weeks
• Onset between 6 and 60 months of age
• No failure-to-thrive if caloric intake is adequate ** Modified Rome IV criteria of functional diarrhoea (Neonate and Toddlersbelow 5 years), must include all of the following:
• Daily painless, recurrent passage of three or more large, unformed stools
• Symptoms last more than 2 weeks (Nelson Pediatric Texbook 21st Edition,Chronic diarrhea)
• Onset between 6 and 60 months of age
• No failure-to-thrive if caloric intake is adequate
• These criteria have been modified in order to align the study to thefunctional diarrhoea condition in the real life.
• Parent is the child's biological or adoptive parent. Legal guardian isdefined as an individual who was authorized under applicable state orlocal law to consent on behalf of a child to general medical care, whengeneral medical care includes participation in research. A guardianalso meant an individual who was authorized to consent on behalf of achild to participate in research.

Exclusion Criteria:

• Carbohydrate malabsorption, diagnosed either clinically (2 weeks exclusion diet withresolution of symptoms) or with proper testing (breath test)*;
• Patients with any of the following chronic gastrointestinal disorders: inflammatorybowel disease, pancreatitis, chronic liver disease, eosinophilic oesophagitis, pepticulcer disease, celiac disease, pseudo-obstruction, small bowel bacterial overgrowth,or Hirschsprung's disease
• Significant chronic health condition requiring specialty care (e.g., lithiasis,ureteropelvic junction obstruction, sickle cell, cerebral palsy, hepatic,hematopoietic, renal, endocrine, or metabolic diseases) that could potentially impactthe child's ability to participate or confound the results of the investigation;
• Gastrointestinal blood loss;
• Recurrent or unexplained fevers;
• Developmental disabilities impairing ability to understand or communicate;
• History of hypersensitivity or allergy to investigational product;
• History of previous abdominal surgeries in the past 3 months;
• Known hypersensitivity to any of the components (active ingredients or excipients) ofthe investigational product;
• Conditions known to producing immunodeficiency (AIDS, other congenitalimmunodeficiency syndromes, drugs therapy with steroids, anticancer drugs, etc.);
• Patients who have received any of the following treatments within the 2 weeks beforethe baseline visit:
• Agents specially developed for achieving adsorbing properties, e.g. kaolin,pectin, bismuth subsalicylate;
• Treatments that modify intestinal secretions, e.g. racecadotril;
• Treatments that modify intestinal motility, e.g. opiates, anti-cholinergicagents;
• Systemic Antibiotics;
• Antiemetic agents.
• Patients who have received probiotics and prebiotics within the 1 week before thebaseline visit, unless they have been taken at stable dose (the use of probiotics andprebiotics in dairy food such as yoghurt, cheese, milk prior to the investigation ispermitted);
• Parents/legal guardians' refusal or inability to give written informed consent toparticipate in the investigation;
• Parents/legal guardians who, in the opinion of the Investigator, are unable to fill upthe electronic patient diary;
• Patients who have participated in any other clinical trial in the last 3 months priorto the start of the investigation.
• Applicable only for patients with Functional gastrointestinal disorder fulfillingRome IV Criteria.