EFFICACY AND SAFETY OF XILOGLUCAN IN ACUTE GASTROENTERITIS IN CHILDREN (PEDXIL01)

RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF XILOGLUCAN IN ACUTE GASTROENTERITIS IN CHILDREN

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.

Study Overview

• Status: Unknown
• Conditions: Diarrhea
• Intervention / Treatment: Other: medical device

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Recruiting
      • Hospital Puerta de Hierro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XYLOGLUCAN; treatment regimen with oral rehydration solution and xyloglucan	Other: medical device; 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
Placebo Comparator: PLACEBO; rehydration solution and placebo.	Other: medical device; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time of resolution of diarrhea	Number of days	14 days

Collaborators and Investigators

• Sponsor: Enriqueta Roamn
• Investigators: Study Director: Enriqueta Roman, PHD, Hospital Universitario Puerta de Hierro Majadahonda

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): January 30, 2018
• Study Completion (Anticipated): July 30, 2018

Study Registration Dates

• First Submitted: November 24, 2017
• First Submitted That Met QC Criteria: November 24, 2017
• First Posted (Actual): November 29, 2017

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Diarrhea; Gastroenteritis
• Other Study ID Numbers: PEDXIL 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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