Treatment of chronic diarrhea in young children with Actitan-F

Efficacy and Safety of Oral Administration of the Plant-based Complex Actitan-F in the Management of Chronic Paediatric Diarrhoea: a Double-blind, Placebo-controlled, Parallel-group Investigation

This study is testing a new treatment for chronic diarrhea in young children aged 1 to 5 to see if it works better than a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 136 (estimated)
• Ages: 1 Year to 5 Years
• Sex: All
• Sponsor: Aboca Spa Societa' Agricola (Industry-sponsored)
• Locations: 12 sites (Napoli, Italia and 11 other locations)
• Trial ID: NCT05904938 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of Lenodiar Pediatric for treating chronic diarrhea in children aged 1 to 5 years. It employs a randomized, double-blind, placebo-controlled design to ensure reliable results. Participants will receive either the active treatment or a placebo, with outcomes assessed through daily diaries maintained by parents or guardians. The study aims to provide insights into effective management strategies for chronic diarrhea in pediatric patients.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 1-5 years diagnosed with chronic diarrhea due to functional gastrointestinal disorders or post-infectious diarrhea.

Not a fit: Patients with diarrhea not meeting the specified criteria or those outside the age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for children suffering from chronic diarrhea.

How similar studies have performed: While similar approaches have been explored, this specific intervention is novel in its application to pediatric chronic diarrhea.

Eligibility criteria

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 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 Toddlers below 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 the functional diarrhoea condition in the real life.

      * Parent is the child's biological or adoptive parent. Legal guardian is defined as an individual who was authorized under applicable state or local law to consent on behalf of a child to general medical care, when general medical care includes participation in research. A guardian also meant an individual who was authorized to consent on behalf of a child to participate in research.

Exclusion Criteria:

* Carbohydrate malabsorption, diagnosed either clinically (2 weeks exclusion diet with resolution of symptoms) or with proper testing (breath test)\*;
* Patients with any of the following chronic gastrointestinal disorders: inflammatory bowel disease, pancreatitis, chronic liver disease, eosinophilic oesophagitis, peptic ulcer 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 impact the 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) of the investigational product;
* Conditions known to producing immunodeficiency (AIDS, other congenital immunodeficiency syndromes, drugs therapy with steroids, anticancer drugs, etc.);
* Patients who have received any of the following treatments within the 2 weeks before the 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-cholinergic agents;
  * Systemic Antibiotics;
  * Antiemetic agents.
* Patients who have received probiotics and prebiotics within the 1 week before the baseline visit, unless they have been taken at stable dose (the use of probiotics and prebiotics in dairy food such as yoghurt, cheese, milk prior to the investigation is permitted);
* Parents/legal guardians' refusal or inability to give written informed consent to participate in the investigation;
* Parents/legal guardians who, in the opinion of the Investigator, are unable to fill up the electronic patient diary;
* Patients who have participated in any other clinical trial in the last 3 months prior to the start of the investigation.

  * Applicable only for patients with Functional gastrointestinal disorder fulfilling Rome IV Criteria.

Where this trial is running

Napoli, Italia and 11 other locations

• Azienda Ospedaliera Universitaria "Federico II", — Napoli, Italia, Italy (Recruiting)
• ASST Papa Giovanni XXIII — Bergamo, Italy (Recruiting)
• Azienda Ospedaliera Cannizzaro, UOC Pediatria e PS Pediatrico — Catania, Italy (Recruiting)
• Policlinico "SS. Annunziata" Clinica Pediatrica Via dei Vestini, Località colle dell'Ara 66100, Chieti — Chieti, Italy (Recruiting)
• IRCCS AOU Meyer SOC Gastroenterologia e Nutrizione, Viale Gaetano Pieraccini 24 — Firenze, Italy (Recruiting)
• Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo Presidio San Carlo, Ambulatorio di Gastroenterologia Pediatrica — Milano, Italy (Recruiting)
• Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli", I Clinica Pediatrica — Napoli, Italy (Recruiting)
• ARNAS Ospedale Civico e Benfratelli G Cristina e M Ascoli, Pediatria ad Indirizzo Gastroenterologico — Palermo, Italy (Not_yet_recruiting)
• Fondazione IRCCS Policlinico San Matteo, Pediatria — Pavia, Italy (Recruiting)
• Ospedale S. Maria della Misericordia — Perugia, Italy (Not_yet_recruiting)
• Ospedale San Jacopo di Pistoia, SOC Pediatria — Pistoia, Italy (Recruiting)
• U.O. di Gastroenterologia e Riabilitazione Nutrizionale Ospedale Pediatrico Bambin Gesu Piazza S. Onofrio, 4 00165, Roma — Roma, Italy (Not_yet_recruiting)

Study contacts

• Study coordinator: Luca Franceschini, Ph. D

Conditions Chronic Diarrhoea of Infants and/or Young Children