EFFICACY AND SAFETY OF XILOGLUCAN IN ACUTE GASTROENTERITIS IN CHILDREN

NCT ID: NCT03357237

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2018-07-30

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.

Conditions

Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

XYLOGLUCAN

treatment regimen with oral rehydration solution and xyloglucan

Group Type: EXPERIMENTAL

medical device

Intervention Type: 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

rehydration solution and placebo.

Group Type: PLACEBO_COMPARATOR

medical device

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Enriqueta Roamn

OTHER

Sponsor Role: lead

Responsible Party

Enriqueta Roamn

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Enriqueta Roman, PHD

Role: STUDY_DIRECTOR

Hospital Universitario Puerta de Hierro Majadahonda

Locations

Hospital Puerta de Hierro

Majadahonda, Madrid, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Maria Jose Garcia, MD

Role: CONTACT

mariajo_p_G@hotmail.com

34911 91 60 00

Other Identifiers

PEDXIL 01

Identifier Type: -

Identifier Source: org_study_id