Back to resultsEFFICACY AND SAFETY OF XILOGLUCAN IN ACUTE GASTROENTERITIS IN CHILDREN (PEDXIL01)
Primary Purpose
Diarrhea
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
medical device
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea
Eligibility Criteria
Inclusion Criteria:
- Clinical of acute gastroenteritis: change in the consistency of stools to "loose" or liquid according to Bristol scale (6 or 7) or Amsterdam (infants) (A) and / or increase in the number of stools (greater or equal to 3 / day) with a duration of less than 72 h
- Age over 3 months and under 5 years
- Written informed consent according to ICH / GCP and local legislation, obtained before any study procedure of parents or guardians
Exclusion Criteria:
- Treatment with antibiotics, xyloglucan, gelatin tannate, racecadotril, smectite, probiotics or zinc (including oral rehydration solution containing zinc and / or probiotics) in the previous week
- Exclusive breastfeeding
- Chronic gastrointestinal disease (celiac disease, cystic fibrosis, inflammatory bowel disease, food allergy)
- Immunodeficiencies
- Malnutrition (weight / height / length less than P3 according to WHO standards)
- Severe dehydration
- Impossibility of follow-up
- Known hypersensitivity to gelatin or xyloglucan
- Absence of informed consent
- Caregivers / parents who can not understand or comply with all the instructions and requirements of the study.
- If in the opinion of the researcher there are findings in the physical examination, abnormalities in the results of the clinical analyzes or other medical, social or psychosocial factors that could negatively influence
Sites / Locations
- Hospital Puerta de HierroRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
XYLOGLUCAN
PLACEBO
Arm Description
treatment regimen with oral rehydration solution and xyloglucan
rehydration solution and placebo.
Outcomes
Primary Outcome Measures
time of resolution of diarrhea
Number of days
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03357237
Brief Title
EFFICACY AND SAFETY OF XILOGLUCAN IN ACUTE GASTROENTERITIS IN CHILDREN
Acronym
PEDXIL01
Official Title
RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF XILOGLUCAN IN ACUTE GASTROENTERITIS IN CHILDREN
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
January 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Enriqueta Roamn
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Acute gastroenteritis (GEA) is an inflammation of the intestinal mucosa that clinically translates into an acute episode of diarrhea and vomiting and is generally associated with an intestinal infectious disease. It is one of the most common diseases in children and an important cause of morbidity and mortality worldwide. The important loss of liquids can lead to dehydration, acidosis and hydroelectrolitic alteration. Infants are more vulnerable to gastrointestinal infection and its consequences, dehydration and malnutrition.
There is no specific treatment, so it is exclusively symptomatic
A new type of products considered as mucoprotectors has been developed, such as gelatin tannate or xyloglucan, still with little data to establish recommendations on its use in the GEA. They would be able to reproduce in the intestine a muco-adhesive film or sheet protective It must be considered in this sense that mucus is the first barrier that protects the gastrointestinal tract against microorganisms or antigens and that bacterial invasion is related to the opening of narrow junctions.
Xyloglucan was approved in Europe as a medical device IIa to restore the physiological functions of the intestinal wall in the form of capsules for adults and envelopes for children.
Detailed Description
A randomized, blinded study with a control group is proposed in this project to establish solidly the efficacy of xyloglucan in the treatment of acute gastroenteritis in children.
The main variable of evaluation will be the duration of diarrhea, defined as the time it takes to normalize the consistency of stools (according to the Bristol or Amsterdam scale) or their number.
Clinical trial in phase IV with medical product type IIa and CE marking, used in the same conditions in which it is marketed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention or experimental group: treatment regimen with oral rehydration solution and xyloglucan
Control or reference group: treatment regimen with oral rehydration solution and placebo.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
XYLOGLUCAN
Arm Type
Experimental
Arm Description
treatment regimen with oral rehydration solution and xyloglucan
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
rehydration solution and placebo.
Intervention Type
Other
Intervention Name(s)
medical device
Intervention Description
patients will be assigned, following an external randomization, to two groups:
Intervention or experimental group: treatment regimen with oral rehydration solution and xyloglucan
Control or reference group: treatment regimen with oral rehydration solution and placebo
Primary Outcome Measure Information:
Title
time of resolution of diarrhea
Description
Number of days
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical of acute gastroenteritis: change in the consistency of stools to "loose" or liquid according to Bristol scale (6 or 7) or Amsterdam (infants) (A) and / or increase in the number of stools (greater or equal to 3 / day) with a duration of less than 72 h
Age over 3 months and under 5 years
Written informed consent according to ICH / GCP and local legislation, obtained before any study procedure of parents or guardians
Exclusion Criteria:
Treatment with antibiotics, xyloglucan, gelatin tannate, racecadotril, smectite, probiotics or zinc (including oral rehydration solution containing zinc and / or probiotics) in the previous week
Exclusive breastfeeding
Chronic gastrointestinal disease (celiac disease, cystic fibrosis, inflammatory bowel disease, food allergy)
Immunodeficiencies
Malnutrition (weight / height / length less than P3 according to WHO standards)
Severe dehydration
Impossibility of follow-up
Known hypersensitivity to gelatin or xyloglucan
Absence of informed consent
Caregivers / parents who can not understand or comply with all the instructions and requirements of the study.
If in the opinion of the researcher there are findings in the physical examination, abnormalities in the results of the clinical analyzes or other medical, social or psychosocial factors that could negatively influence
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Jose Garcia, MD
Phone
34911 91 60 00
Email
mariajo_p_G@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enriqueta Roman, PHD
Organizational Affiliation
Hospital Universitario Puerta de Hierro Majadahonda
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
EFFICACY AND SAFETY OF XILOGLUCAN IN ACUTE GASTROENTERITIS IN CHILDREN
We'll reach out to this number within 24 hrs