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Oral Administration of Actitan-F in Paediatric Diarrhoea

Primary Purpose

Chronic Diarrhoea of Infants and/or Young Children

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lenodiar Pediatric
Placebo
Sponsored by
Aboca Spa Societa' Agricola
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Diarrhoea of Infants and/or Young Children

Eligibility Criteria

1 Year - 5 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lenodiar Pediatric

Placebo

Arm Description

Medical Device

Placebo

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change for daily daytime and nighttime stool consistency scores
Change for daily daytime and nighttime stool consistency scores assessed using the Bristol Stool Form Scale (BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).
Change for 24-hour abdominal pain scores
Abdominal Pain is scored on a five-point ordinal scale, with 0 meaning no pain, and 4 meaning a lot of pain.
Change for daytime, nighttime, and 24-hour bowel movement frequency
Change for daytime, nighttime, and 24-hour bowel movement frequency
Change for daytime, nighttime, and 24-hour urgency-free days
Change for daytime, nighttime, and 24-hour urgency-free days (only for patients who have removed the diaper and have received training toilet)
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.
Time to event is defined as the time elapsed (days) from the date of randomization to the date of the first week in which a reduction ≥50% of loose or watery stools as compared to baseline occurs. This endpoint will be assessed through electronic diary.
Use of other treatments (proportion of users) for diarrhea relief, evaluated by means of the electronic patient diaries;
Use of other treatments (proportion of users and quantity) for diarrhea relief, evaluated through a electronic patient diaries;
Use of other treatments (quantity of other treatments) for diarrhea relief, evaluated by means of the electronic patient diaries;
Use of other treatments (proportion of users and quantity) for diarrhea relief, evaluated through a electronic patient diaries;
Change in results of the Pediatric Quality of Life Questionnaires
Change in results of the Pediatric Quality of Life Questionnaires assessed through a validated questionnaire
Change in results of the patient happiness using a weekly smiley likert scale
Parents/legal guardians will report, on a weekly basis, the happiness of the patients using a smiley face likert scale (Very happy; Happy; Slightly happy; Neutral; Slightly unhappy)
Change in results in parent Quality of Life (100 mm VAS)
Change in results in parent Quality of Life using a 100 mm Visual Analogie Scale, ranging from "0" (corresponds to a quality of life "very low") and the value "100" (corresponds to a quality of life "very high")
Time to event, with the event defined as the first day in which loose or watery stools are not observed.
Time to event is defined as the time elapsed (days) from the date of randomization to the date of the first day in which loose or watery stools are not observed.
Change in patients' lifestyle
Change in patients' lifestyle assessed through a lifestyle questionnaire
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.
Time to event is defined as the time elapsed (days) from the date of randomization to the date of the third of the first consecutive three days in which diagnostic criteria for chronic diarrhoea are no more met
Change from baseline in stool consistency at day 3, day 7 and day 10.
Change from baseline in stool consistency at day 3, day 7 and day 10. Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).
Adverse Event
Incidence of adverse events (AEs)
Serious Adverse Event
Incidence of serious adverse events (SAEs)
Adverse device effects
Incidence of adverse device effects (ADEs)
Serious adverse device effects
Incidence of a serious adverse device effects (SADEs)
Unexpected serious adverse device effects
Incidence of unexpected serious adverse device effects (USADEs)
Early withdrawal rate due to AEs
Incidence of early withdrawal rate due to AEs, whether serious or not
Safety Endpoints - early withdrawal rate due to ADEs
Incidence of early withdrawal rate due to ADEs, whether serious or not.
Systolic/diastolic blood pressure
Change from baseline in clinical examination findings (systolic/diastolic blood pressure)
Pulse
Change from baseline in clinical examination findings (pulse)
Weight
Change from baseline in clinical examination findings (weight)
Body Mass Index
Change from baseline in clinical examination findings (Body Mass Index)
Waist circumference
Change from baseline in clinical examination findings (waist circumference)

Full Information

First Posted
March 16, 2023
Last Updated
July 13, 2023
Sponsor
Aboca Spa Societa' Agricola
Collaborators
IQVIA RDS, IQVIA Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT05904938
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aboca Spa Societa' Agricola
Collaborators
IQVIA RDS, IQVIA Solutions

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Diarrhoea of Infants and/or Young Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double blind
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lenodiar Pediatric
Arm Type
Experimental
Arm Description
Medical Device
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Device
Intervention Name(s)
Lenodiar Pediatric
Intervention Description
Medical Device made of natural substance
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Product appearance similar to verum without clinical efficacy
Primary Outcome Measure Information:
Title
Change from baseline in stool consistency averaged over the 2-week Treatment Period
Description
Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).
Time Frame
Up to 2 weeks vs Baseline
Secondary Outcome Measure Information:
Title
Change for daily daytime and nighttime stool consistency scores
Description
Change for daily daytime and nighttime stool consistency scores assessed using the Bristol Stool Form Scale (BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).
Time Frame
(Week1 to Week4) vs Baseline
Title
Change for 24-hour abdominal pain scores
Description
Abdominal Pain is scored on a five-point ordinal scale, with 0 meaning no pain, and 4 meaning a lot of pain.
Time Frame
(Week1 to Week4) vs Baseline
Title
Change for daytime, nighttime, and 24-hour bowel movement frequency
Description
Change for daytime, nighttime, and 24-hour bowel movement frequency
Time Frame
(Week1 to Week4) vs Baseline
Title
Change for daytime, nighttime, and 24-hour urgency-free days
Description
Change for daytime, nighttime, and 24-hour urgency-free days (only for patients who have removed the diaper and have received training toilet)
Time Frame
(Week1 to Week4) vs Baseline
Title
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.
Description
Time to event is defined as the time elapsed (days) from the date of randomization to the date of the first week in which a reduction ≥50% of loose or watery stools as compared to baseline occurs. This endpoint will be assessed through electronic diary.
Time Frame
through study completion, an average of 4 weeks
Title
Use of other treatments (proportion of users) for diarrhea relief, evaluated by means of the electronic patient diaries;
Description
Use of other treatments (proportion of users and quantity) for diarrhea relief, evaluated through a electronic patient diaries;
Time Frame
through study completion, an average of 4 weeks
Title
Use of other treatments (quantity of other treatments) for diarrhea relief, evaluated by means of the electronic patient diaries;
Description
Use of other treatments (proportion of users and quantity) for diarrhea relief, evaluated through a electronic patient diaries;
Time Frame
through study completion, an average of 4 weeks
Title
Change in results of the Pediatric Quality of Life Questionnaires
Description
Change in results of the Pediatric Quality of Life Questionnaires assessed through a validated questionnaire
Time Frame
Visit 1 (day 14); Visit 2 (day 28);
Title
Change in results of the patient happiness using a weekly smiley likert scale
Description
Parents/legal guardians will report, on a weekly basis, the happiness of the patients using a smiley face likert scale (Very happy; Happy; Slightly happy; Neutral; Slightly unhappy)
Time Frame
through study completion, an average of 4 weeks
Title
Change in results in parent Quality of Life (100 mm VAS)
Description
Change in results in parent Quality of Life using a 100 mm Visual Analogie Scale, ranging from "0" (corresponds to a quality of life "very low") and the value "100" (corresponds to a quality of life "very high")
Time Frame
Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Title
Time to event, with the event defined as the first day in which loose or watery stools are not observed.
Description
Time to event is defined as the time elapsed (days) from the date of randomization to the date of the first day in which loose or watery stools are not observed.
Time Frame
through study completion, an average of 4 weeks
Title
Change in patients' lifestyle
Description
Change in patients' lifestyle assessed through a lifestyle questionnaire
Time Frame
Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Title
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.
Description
Time to event is defined as the time elapsed (days) from the date of randomization to the date of the third of the first consecutive three days in which diagnostic criteria for chronic diarrhoea are no more met
Time Frame
through study completion, an average of 4 weeks
Title
Change from baseline in stool consistency at day 3, day 7 and day 10.
Description
Change from baseline in stool consistency at day 3, day 7 and day 10. Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).
Time Frame
Baseline to day 3, day 7 and day 10
Title
Adverse Event
Description
Incidence of adverse events (AEs)
Time Frame
through study completion, an average of 4 weeks
Title
Serious Adverse Event
Description
Incidence of serious adverse events (SAEs)
Time Frame
through study completion, an average of 4 weeks
Title
Adverse device effects
Description
Incidence of adverse device effects (ADEs)
Time Frame
through study completion, an average of 4 weeks
Title
Serious adverse device effects
Description
Incidence of a serious adverse device effects (SADEs)
Time Frame
through study completion, an average of 4 weeks
Title
Unexpected serious adverse device effects
Description
Incidence of unexpected serious adverse device effects (USADEs)
Time Frame
through study completion, an average of 4 weeks
Title
Early withdrawal rate due to AEs
Description
Incidence of early withdrawal rate due to AEs, whether serious or not
Time Frame
through study completion, an average of 4 weeks
Title
Safety Endpoints - early withdrawal rate due to ADEs
Description
Incidence of early withdrawal rate due to ADEs, whether serious or not.
Time Frame
through study completion, an average of 4 weeks
Title
Systolic/diastolic blood pressure
Description
Change from baseline in clinical examination findings (systolic/diastolic blood pressure)
Time Frame
Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Title
Pulse
Description
Change from baseline in clinical examination findings (pulse)
Time Frame
Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Title
Weight
Description
Change from baseline in clinical examination findings (weight)
Time Frame
Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Title
Body Mass Index
Description
Change from baseline in clinical examination findings (Body Mass Index)
Time Frame
Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Title
Waist circumference
Description
Change from baseline in clinical examination findings (waist circumference)
Time Frame
Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Other Pre-specified Outcome Measures:
Title
Faecal microbiota
Description
Differences before and after treatment in the analyses of Faecal microbiota, collecting and analysing stool samples
Time Frame
Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Title
Faecal metabolomics
Description
Differences before and after treatment in the analyses of Faecal metabolomics, , collecting and analysing stool samples.
Time Frame
Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)
Title
Micro RNA
Description
Differences before and after treatment in the analyses of Micro RNA (miRNA) from mouth epithelial cells, , collecting and analysing buccal samples
Time Frame
Baseline to Visit 1 (day 14) and Visit 2 (day 28) and Visit 1 (day 14) to Visit 2 (day 28)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luca Franceschini, Ph. D
Phone
+39 3386794491
Email
lfranceschini@aboca.it
Facility Information:
Facility Name
Azienda Ospedaliera Universitaria "Federico II",
City
Napoli
State/Province
Italia
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annamaria Staiano, Professor
Phone
+39817462679
Email
staiano@unina.it
Facility Name
Azienda Ospedaliera Cannizzaro, UOC Pediatria e PS Pediatrico
City
Catania
ZIP/Postal Code
95126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonella Di Stefano, Professor
Phone
+39957264334
Email
vitantonelladistefano@gmail.com
Facility Name
Policlinico "SS. Annunziata" Clinica Pediatrica Via dei Vestini, Località colle dell'Ara 66100, Chieti
City
Chieti
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Chiarelli, Professor
Email
chiarelli@unich.it
Facility Name
IRCCS AOU Meyer SOC Gastroenterologia e Nutrizione, Viale Gaetano Pieraccini 24
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Lionetti, Professor
Email
paolo.lionetti@unifi.it
Facility Name
Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo Presidio San Carlo, Ambulatorio di Gastroenterologia Pediatrica
City
Milano
ZIP/Postal Code
20135
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Ghisleni, Professor
Phone
+02/8184.4171
Email
diana.ghisleni@asst-santipaolocarlo.it
Facility Name
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli", I Clinica Pediatrica
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caterina Strisciuglio, Professor
Phone
081 566 5445
Email
caterina.strisciuglio@unicampania.it
Facility Name
ARNAS Ospedale Civico e Benfratelli G Cristina e M Ascoli, Pediatria ad Indirizzo Gastroenterologico
City
Palermo
ZIP/Postal Code
90134
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Cavataio, Professor
Phone
+39916666197
Email
francesca.cavataio@arnascivico.it
Facility Name
Fondazione IRCCS Policlinico San Matteo, Pediatria
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Maria Elena Caimmi, Professor
Phone
+390382502923
Email
gl.marseglia@smatteo.pv.it
Facility Name
Ospedale San Jacopo di Pistoia, SOC Pediatria
City
Pistoia
ZIP/Postal Code
51100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rino Agostiniani, Professor
Phone
+39573367379
Email
rinoagostiniani@gmail.com
Facility Name
U.O. di Gastroenterologia e Riabilitazione Nutrizionale Ospedale Pediatrico Bambin Gesu Piazza S. Onofrio, 4 00165, Roma
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonella Diamanti, Professor
Email
antonella.diamanti@opbg.net

12. IPD Sharing Statement

Learn more about this trial

Oral Administration of Actitan-F in Paediatric Diarrhoea

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