Clinical trial NCT05904938: Oral Administration of Actitan-F in Paediatric Diarrhoea
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Diarrhoea of Infants and/or Young Children
Lead sponsor: Aboca Spa Societa' Agricola
Sponsor class: INDUSTRY
Collaborators: name: IQVIA RDS Inc.
name: IQVIA Solutions
First posted: 2023-06-15
Enrollment: 136
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


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.

Primary outcomes:
measure: Change from baseline in stool consistency averaged over the 2-week Treatment Period
timeFrame: Up to 2 weeks vs Baseline
Secondary outcomes:
measure: Change for daily daytime and nighttime stool consistency scores
timeFrame: (Week1 to Week4) vs Baseline
measure: Change for 24-hour abdominal pain scores
timeFrame: (Week1 to Week4) vs Baseline
measure: Change for daytime, nighttime, and 24-hour bowel movement frequency
timeFrame: (Week1 to Week4) vs Baseline
measure: Change for daytime, nighttime, and 24-hour urgency-free days
timeFrame: (Week1 to Week4) vs Baseline
measure: Time to event, with the event defined as the first week in which a reduction ≥50% of loose or watery stools as compared to baseline occurs.
timeFrame: through study completion, an average of 4 weeks
measure: Use of other treatments (proportion of users) for diarrhea relief, evaluated by means of the electronic patient diaries;
timeFrame: through study completion, an average of 4 weeks
measure: Use of other treatments (quantity of other treatments) for diarrhea relief, evaluated by means of the electronic patient diaries;
timeFrame: through study completion, an average of 4 weeks
measure: Change in results of the Pediatric Quality of Life Questionnaires
timeFrame: Visit 1 (day 14); Visit 2 (day 28);
measure: Change in results of the patient happiness using a weekly smiley likert scale
timeFrame: through study completion, an average of 4 weeks
measure: Change in results in parent Quality of Life (100 mm VAS)
timeFrame: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
measure: Time to event, with the event defined as the first day in which loose or watery stools are not observed.
timeFrame: through study completion, an average of 4 weeks
measure: Change in patients' lifestyle
timeFrame: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
measure: Time to event, with the event defined as the third day of the first consecutive three days in which diagnostic criteria for chronic diarrhoea are no more met.
timeFrame: through study completion, an average of 4 weeks
measure: Change from baseline in stool consistency at day 3, day 7 and day 10.
timeFrame: Baseline to day 3, day 7 and day 10
measure: Adverse Event
timeFrame: through study completion, an average of 4 weeks
measure: Serious Adverse Event
timeFrame: through study completion, an average of 4 weeks
measure: Adverse device effects
timeFrame: through study completion, an average of 4 weeks
measure: Serious adverse device effects
timeFrame: through study completion, an average of 4 weeks
measure: Unexpected serious adverse device effects
timeFrame: through study completion, an average of 4 weeks
measure: Early withdrawal rate due to AEs
timeFrame: through study completion, an average of 4 weeks
measure: Safety Endpoints - early withdrawal rate due to ADEs
timeFrame: through study completion, an average of 4 weeks
measure: Systolic/diastolic blood pressure
timeFrame: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
measure: Pulse
timeFrame: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
measure: Weight
timeFrame: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
measure: Body Mass Index
timeFrame: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
measure: Waist circumference
timeFrame: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Other outcomes:
measure: Faecal microbiota
timeFrame: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
measure: Faecal metabolomics
timeFrame: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
measure: Micro RNA
timeFrame: Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Locations:
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria "Federico II",
state: Italia
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
city: Catania
country: Italy
facility: Azienda Ospedaliera Cannizzaro, UOC Pediatria e PS Pediatrico
city: Chieti
country: Italy
facility: Policlinico "SS. Annunziata" Clinica Pediatrica Via dei Vestini, Località colle dell'Ara 66100, Chieti
city: Firenze
country: Italy
facility: IRCCS AOU Meyer SOC Gastroenterologia e Nutrizione, Viale Gaetano Pieraccini 24
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo Presidio San Carlo, Ambulatorio di Gastroenterologia Pediatrica
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli", I Clinica Pediatrica
city: Palermo
country: Italy
facility: ARNAS Ospedale Civico e Benfratelli G Cristina e M Ascoli, Pediatria ad Indirizzo Gastroenterologico
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo, Pediatria
city: Perugia
country: Italy
facility: Ospedale S. Maria della Misericordia
city: Pistoia
country: Italy
facility: Ospedale San Jacopo di Pistoia, SOC Pediatria
city: Roma
country: Italy
facility: U.O. di Gastroenterologia e Riabilitazione Nutrizionale Ospedale Pediatrico Bambin Gesu Piazza S. Onofrio, 4 00165, Roma
Study officials:
References: