EFFICACY AND SAFETY OF XILOGLUCAN IN ACUTE GASTROENTERITIS IN CHILDREN

NCT03357237 | Unknown

• 1 other identifier: PEDXIL 01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea

Outcome Measures

Primary Outcomes (1)

• time of resolution of diarrhea

  Number of days

  14 days

Study Arms (2)

XYLOGLUCAN

EXPERIMENTAL

treatment regimen with oral rehydration solution and xyloglucan

Other: medical device

PLACEBO

PLACEBO COMPARATOR

rehydration solution and placebo.

Other: medical device

Interventions

medical device OTHER

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; XYLOGLUCAN

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Enriqueta Roamn: lead

Study Sites (1)

Hospital Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

RECRUITING

MeSH Terms

Conditions

Diarrhea

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Enriqueta Roman, PHD

  Hospital Universitario Puerta de Hierro Majadahonda

  STUDY DIRECTOR

Central Study Contacts

Maria Jose Garcia, MD

CONTACT

34911 91 60 00; mariajo_p_G@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: * Intervention or experimental group: treatment regimen with oral rehydration solution and xyloglucan * Control or reference group: treatment regimen with oral rehydration solution and placebo.

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: November 29, 2017
• Study Start: December 1, 2017
• Primary Completion: January 30, 2018
• Study Completion: July 30, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

ES (1)