Novel Diagnostics and Probiotics to Improve Management of Paediatric Acute Gastroenteritis

Phase 4CompletedNCT02025452

Jeffrey Pernica76 enrolled

Overview

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. We will conduct a randomized trial to see if rapid testing using novel methods to identify potentially treatable causes of diarrhoea leads to improved outcomes. We will also be randomizing children to probiotic therapy versus placebo (the standard of care) to see if this treatment decreases the duration of diarrhoea. The proposed study is a pilot trial, necessary before embarking on a large multi-centre trial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Acute Gastroenteritis

Interventions

Specimens from rectal mucosa will be obtained using flocked swabs at enrolment. Those in 'rapid diagnostic' groups will have them tested using multiplex PCR the day of enrolment and participants with treatable pathogens will have antimicrobials provided. Those in 'delayed diagnostic' groups will have the swabs batched at tested at the conclusion of the study, being treated as per standard of care.

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 60 Months

Medical Language ↔ Plain English

Inclusion Criteria: * acute non-bloody gastroenteritis Exclusion Criteria: * diarrhoea \> 14 days * sepsis, pneumonia, UTI, meningitis requiring empiric antibiotic therapy * malignancy, IBD * known link to another patient with diarrhoea of defined aetiology * transferred in already on antimicrobials * live outside study area * children with severe acute malnutrition will be eligible for diagnostic arm but not probiotic arm

Locations (3)

Princess Marina Hospital

Gaborone, Botswana

Scottish Livingstone Hospital

Molepolole, Botswana

Bamalete Lutheran Hospital

Ramotswa, Botswana

Outcomes

Primary Outcomes

Height z-score (HAZ) adjusted for initial HAZ

Time frame: 60 days post-enrollment

Secondary Outcomes

mortality

Time frame: 60 days post-enrollment

environmental enteropathy score

Time frame: 60 days post-enrollment

duration of diarrhoea

Note that presence of diarrhoea will be checked daily during admission. Total duration of diarrhoea will be verified with the caregiver by telephone 7 days after the participant was discharged home.

Time frame: estimated average duration ~ 4 days.

Weight z-score (WAZ) adjusted for initial WAZ

Time frame: 60 days after enrolment