Optimizing the Management of Acute Diarrhoeal Disease
- Conditions
- Acute Gastroenteritis
- Interventions
- Other: Rapid diagnosticsBiological: ProbioticOther: Placebo
- Registration Number
- NCT02803827
- Lead Sponsor
- Hamilton Health Sciences Corporation
- Brief Summary
Many children admitted to hospital in Botswana without bloody diarrhoea are presumed to have viral gastroenteritis and so not treated with antibiotics - but they may indeed have a treatable cause for their illness. The investigators will conduct a randomized trial to see if rapid testing using novel methods to identify potentially treatable causes of diarrhoea leads to improved outcomes. The investigators will also be randomizing children to Lactobacillus reuteri DSM (daughter strain) 17938 therapy versus placebo (the standard of care) to see if this treatment decreases the duration of diarrhoea. The proposed study is a large multi-centre trial following the previous pilot trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 276
- acute diarrhoeal illness (>= 3 stools in 24 hour period)
- diarrhoeal illness >=14 days
- bloody stool
- known inflammatory bowel disease, cystic fibrosis, or malignancy
- live in a household with someone else documented to have a bacterial or parasitic enteric infection of defined aetiology
- live outside catchment areas
- no permanent address
- no access to mobile phone
- previous participation in this study
- nosocomial diarrhoea
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Rapid diagnostics and probiotic Probiotic Participants randomized to this arm will have rapid enteric diagnostics performed on the day of enrolment. Those found to have a treatable pathogen will be prescribed antimicrobials that day. Participants will also be given Lactobacillus reuteri DSM 17938 5 x 10e8 cfu/mL x 60 days. No rapid diagnostics and probiotic Probiotic Participants randomized to this arm will have stool specimens processed after the conclusion of the study. Participants will also be given Lactobacillus reuteri DSM 17938 5 x 10e8 cfu/mL x 60 days. Rapid diagnostics and probiotic Rapid diagnostics Participants randomized to this arm will have rapid enteric diagnostics performed on the day of enrolment. Those found to have a treatable pathogen will be prescribed antimicrobials that day. Participants will also be given Lactobacillus reuteri DSM 17938 5 x 10e8 cfu/mL x 60 days. Rapid diagnostics and placebo Rapid diagnostics Participants randomized to this arm will have rapid enteric diagnostics performed on the day of enrolment. Those found to have a treatable pathogen will be prescribed antimicrobials that day. Participants will also be given placebo x 60 days. Rapid diagnostics and placebo Placebo Participants randomized to this arm will have rapid enteric diagnostics performed on the day of enrolment. Those found to have a treatable pathogen will be prescribed antimicrobials that day. Participants will also be given placebo x 60 days. No rapid diagnostics and placebo Placebo Participants randomized to this arm will have stool specimens processed after the conclusion of the study. Participants will also be given placebo x 60 days.
- Primary Outcome Measures
Name Time Method Height z-score (HAZ) adjusted for baseline HAZ 60 days post-enrollment
- Secondary Outcome Measures
Name Time Method Environmental enteropathy score (EES) 60 days composite of stool neopterin, myeloperoxidase, and alpha-1-antitrypsin
Diarrhoea recurrence 60 days after enrolment Mortality 60 days post-enrollment Weight z-score (WAZ) adjusted for baseline WAZ 60 days post-enrollment
Trial Locations
- Locations (4)
Scottish Livingstone Hospital
🇧🇼Molepolole, Botswana
Bamalete Lutheran Hospital
🇧🇼Ramotswa, Botswana
Princess Marina Hospital
🇧🇼Gaborone, Botswana
Deborah Retief Hospital
🇧🇼Mochudi, Botswana