Oral Administration of Actitan-F in Paediatric Diarrhoea

NCT05904938 | Unknown

• 1 other identifier: ABO-LENP-01/22
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 12

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

Conditions

Chronic Diarrhoea of Infants and/or Young Children

Outcome Measures

Primary Outcomes (1)

• Change from baseline in stool consistency averaged over the 2-week Treatment Period

  Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).

  Up to 2 weeks vs Baseline

Secondary Outcomes (26)

• Change for daily daytime and nighttime stool consistency scores

  (Week1 to Week4) vs Baseline

• Change for 24-hour abdominal pain scores

  (Week1 to Week4) vs Baseline

• Change for daytime, nighttime, and 24-hour bowel movement frequency

  (Week1 to Week4) vs Baseline

• Change for daytime, nighttime, and 24-hour urgency-free days

  (Week1 to Week4) vs Baseline

• 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.

  through study completion, an average of 4 weeks

Other Outcomes (3)

• Faecal microbiota

  Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)

• Faecal metabolomics

  Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)

• Micro RNA

  Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)

Study Arms (2)

Lenodiar Pediatric

EXPERIMENTAL

Medical Device

Device: Lenodiar Pediatric

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Lenodiar Pediatric DEVICE

Medical Device made of natural substance

Lenodiar Pediatric

Placebo OTHER

Product appearance similar to verum without clinical efficacy

Placebo

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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\*
• Functional gastrointestinal disorder fulfilling modified Rome IV Criteria \*\*
• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aboca Spa Societa' Agricola: lead
• IQVIA RDS Inc.: collaborator
• IQVIA Solutions: collaborator

Study Sites (12)

Azienda Ospedaliera Universitaria "Federico II",

Napoli, Italia, 80131, Italy

RECRUITING

ASST Papa Giovanni XXIII

Bergamo, Italy

RECRUITING

Azienda Ospedaliera Cannizzaro, UOC Pediatria e PS Pediatrico

Catania, 95126, 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

Florence, 50139, Italy

RECRUITING

Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo Presidio San Carlo, Ambulatorio di Gastroenterologia Pediatrica

Milan, 20135, Italy

RECRUITING

Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli", I Clinica Pediatrica

Napoli, 80138, Italy

RECRUITING

ARNAS Ospedale Civico e Benfratelli G Cristina e M Ascoli, Pediatria ad Indirizzo Gastroenterologico

Palermo, 90134, Italy

NOT YET RECRUITING

Fondazione IRCCS Policlinico San Matteo, Pediatria

Pavia, 27100, Italy

RECRUITING

Ospedale S. Maria della Misericordia

Perugia, Italy

NOT YET RECRUITING

Ospedale San Jacopo di Pistoia, SOC Pediatria

Pistoia, 51100, Italy

RECRUITING

U.O. di Gastroenterologia e Riabilitazione Nutrizionale Ospedale Pediatrico Bambin Gesu Piazza S. Onofrio, 4 00165, Roma

Roma, Italy

NOT YET RECRUITING

Central Study Contacts

Luca Franceschini, Ph. D

CONTACT

+39 3386794491; lfranceschini@aboca.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: June 15, 2023
• Study Start: July 10, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 7, 2024

Record last verified: 2023-06

Locations

IT (12)