Trial to evaluate the efficacy and safety of a combination of xyloglucan and gelose associated to oral rehydration salts for the treatment of acute diarrhea in childre

Phase 4

Completed

• Conditions: Acute diarrhea; Digestive System

• Registration Number: ISRCTN61965252
• Lead Sponsor: OVENTURE S.L.

Brief Summary

2021 results in https://pubmed.ncbi.nlm.nih.gov/33028102/ (added 12/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-11-29
• Study Start: 2020-04-24
• Last Update Posted: 24 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Acute gastroenteritis defined as a change in stool consistency according to the Bristol Stool Form (BSF) scale and/or an increase in the frequency of evacuations (typically =3 in 24 h) lasting more than 1 day and no longer than 3 days
2. Age group of children between = 3 months and = 14 years
3. A caregiver must provide written informed consent

Exclusion Criteria

1. Use of antibiotics, gelatine tannate, diosmectite, other probiotics, racecadotril, or zinc (including zinc containing ORS) within a week prior to enrolment
2. Exclusive breast feeding
3. Chronic diarrheal gastrointestinal disease (eg. inflammatory bowel diseases, cystic fibrosis, coeliac disease, food allergy)
4. Immunodeficiencies
5. Malnutrition (weight/height/length under 3rd percentile) (WHO Child Growth Standards will be used)
6. If needed, discontinuation or modification of the treatment may be considered at the discretion of the physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified