Clinical trial NCT02803827: Optimizing the Management of Acute Diarrhoeal Disease
Official title: Optimizing the Management of Pediatric Acute Diarrhoeal Disease in Botswana
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Gastroenteritis
Keywords: diarrhoea
gastroenteritis
rapid diagnostics
probiotics
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: BioMérieux
name: BioGaia AB
name: Copan Italia S.A.
name: Botswana-UPenn Partnership
name: University of British Columbia
First posted: 2016-06-17
Enrollment: 276
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* acute diarrhoeal illness (\>= 3 stools in 24 hour period)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Height z-score (HAZ) adjusted for baseline HAZ
timeFrame: 60 days post-enrollment
Secondary outcomes:
measure: Mortality
timeFrame: 60 days post-enrollment
measure: Weight z-score (WAZ) adjusted for baseline WAZ
timeFrame: 60 days post-enrollment
measure: Environmental enteropathy score (EES)
timeFrame: 60 days
measure: Diarrhoea recurrence
timeFrame: 60 days after enrolment
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: Princess Marina Hospital
city: Mochudi
country: Botswana
facility: Deborah Retief Hospital
city: Molepolole
country: Botswana
facility: Scottish Livingstone Hospital
city: Ramotswa
country: Botswana
facility: Bamalete Lutheran Hospital
Study officials:
affiliation: McMaster University
name: Jeffrey Pernica, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pernica JM, Arscott-Mills T, Steenhoff AP, Mokomane M, Moorad B, Bapabi M, Lechiile K, Mangwegape O, Batisani B, Mawoko N, Muthoga C, Vanniyasingam T, Ewusie J, Lowe A, Bonsu JM, Gezmu AM, Smieja M, Mazhani L, Stordal K, Thabane L, Kelly MS, Goldfarb DM. Optimising the management of childhood acute diarrhoeal disease using a rapid test-and- treat strategy and/or Lactobacillus reuteri DSM 17938: a multicentre, randomised, controlled, factorial trial in Botswana. BMJ Glob Health. 2022 Apr;7(4):e007826. doi: 10.1136/bmjgh-2021-007826.