Probiotic treatment for acute watery diarrhoea in Vietnamese childre

Not Applicable

Completed

• Conditions: Acute diarrhoea; Infections and Infestations; Other and unspecified gastroenteritis of infectious origin

• Registration Number: ISRCTN88101063
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

2013 protocol in www.ncbi.nlm.nih.gov/pubmed/23356823 2017 results in https://pubmed.ncbi.nlm.nih.gov/28438140/ (added 15/10/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-14
• Study Completion: 2015-09-26
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Between 9 to 60 months of age with acute, non-bloody, non-mucoid, watery diarrhoea presenting at a study site with symptoms of less than 3 days duration, and
2. Written informed consent from a parent or guardian

We used the definition of diarrhoea as defined by the WHO diarrhoea treatment guidelines: the passage of unusually loose or watery stools, usually at least three times in a 24 hour period ±4.

Exclusion Criteria

1. Patients with bloody or mucoid diarrhoea
2. Those who had >= 1 episode of diarrhoeal disease in the month prior to admission
3. Those who are known to have short bowel syndrome
4. Another underlying chronic (inflammatory) gastrointestinal disease
5. Systemic illnesses rendering the patient immunocompromised
6. Those on chronic steroid therapy
7. Those on immunosuppressive therapy, or
8. Those diagnosed as severely dehydrated, according to the definitions of the WHO guidelines for the treatment of diarrhoea, a manual for physicians and other senior health workers

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The time from the first dose of study medication to the start of the first 24 hour diarrhoea free-period as assessed by the parents/guardians