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

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ClinicalTrials.gov Identifier: NCT03357237
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Enriqueta Roamn, Puerta de Hierro University Hospital

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.


Condition or disease Intervention/treatment Phase
Diarrhea Other: medical device Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF XILOGLUCAN IN ACUTE GASTROENTERITIS IN CHILDREN
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : January 30, 2018
Estimated Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. time of resolution of diarrhea [ Time Frame: 14 days ]
    Number of days



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Ages Eligible for Study:   3 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357237


Contacts
Contact: Maria Jose Garcia, MD 34911 91 60 00 mariajo_p_G@hotmail.com

Locations
Spain
Hospital Puerta de Hierro Recruiting
Majadahonda, Madrid, Spain, 28222
Sponsors and Collaborators
Enriqueta Roamn
Investigators
Study Director: Enriqueta Roman, PHD Hospital Universitario Puerta de Hierro Majadahonda

Responsible Party: Enriqueta Roamn, MD, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier: NCT03357237     History of Changes
Other Study ID Numbers: PEDXIL 01
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Diarrhea
Gastroenteritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases