Status:
UNKNOWN
EFFICACY AND SAFETY OF XILOGLUCAN IN ACUTE GASTROENTERITIS IN CHILDREN
Lead Sponsor:
Enriqueta Roamn
Conditions:
Diarrhea
Eligibility:
All Genders
3-5 years
Phase:
NA
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 infecti...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03357237
Start Date
December 1 2017
End Date
July 30 2018
Last Update
May 11 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain, 28222