Acute diarrhoea Infections and Infestations Other and unspecified gastroenteritis of infectious origin
Conditions
Interventions
Current interventions as of 22/09/2014:
Lactobacillus acidophilus 2 x 10^8 (CFU) twice per day for the duration of 5 days versus placebo, twice daily for the duration of 5 days
both to be dissolved in water and ingested orally.
Previous interventions:
Lactobacillus acidophilus 2 x 10^9 (CFU) twice per day for the duration of 5 days versus pla
both to be dissolved in water and ingested orally.
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 18/09/2014: 1. The total duration of acute watery diarrhoea (including the pre-enrolment duration), from admission to the start of the first 24-hour diarrhoea-free period, as assessed by the participant's parent/guardian 2. Treatment failure: 2.1. No resolution of diarrhoea after 5 days of treatment course 2.2. Severe symptoms for which treatment is stopped, such as the development of severe dehydration, renal failure, (septic) shock, respiratory distress, or other syndromes associated with diarrhoeal disease (e.g. pneumonia) 2.3. Required additional anti-diarrhoeal treatment 3. The stool frequency in the first three days after the first dose of study medication as assessed by the nurse 4. The daily norovirus and rotavirus load in copies per millilitre of viral transport medium, by PCR on faecal swabs from admission until discharge, and at follow-up 5. The duration of hospitalisation defined as the number of days from hospital admission until discharge 6. The extent of intestinal L. acidophilus colonisation of faecal samples collected on admission, on discharge, and at outpatient follow-up Secondary outcome measures from 11/07/2012 to 18/09/2014: 1. The time from the first dose of study medication to the start of the first 24-hour diarrhoea-free period, as assessed by the nurse on duty 2. The total duration of acute watery diarrhoea (including the pre-enrolment duration), from admission to the start of the first 24 hour diarrhoea free-period, as assessed by the participant's parent/guardian 3. Treatment failure: 3.1. No resolution of diarrhoea after 5 days of treatment course 3.2. Severe symptoms for which treatment is stopped, such as the development of severe dehydration, renal failure, | — |
Countries
Viet Nam
Outcome results
None listed