Novel Diagnostics and Probiotics to Improve Management of Paediatric Acute Gastroenteritis

Phase 4

Completed

• Conditions: Acute Gastroenteritis
• Interventions: Other: Rapid diagnostic; Other: Placebo; Dietary Supplement: Probiotic

• Registration Number: NCT02025452
• Lead Sponsor: Jeffrey Pernica

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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-28
• Study First Submitted QC: 2013-12-31
• Study First Posted: 2014-01-01
• Study Start: 2014-03
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Rapid diagnostics and probiotic	Rapid diagnostic	-
Rapid diagnostics and probiotic	Probiotic	-
Delayed diagnostics and placebo	Placebo	-
Rapid diagnostics and placebo	Rapid diagnostic	-
Rapid diagnostics and placebo	Placebo	-
Delayed diagnostics and probiotic	Probiotic	-

Primary Outcome Measures

Name	Time	Method
Height z-score (HAZ) adjusted for initial HAZ	60 days post-enrollment

Secondary Outcome Measures

Name	Time	Method
duration of diarrhoea	estimated average duration ~ 4 days.	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.
mortality	60 days post-enrollment
environmental enteropathy score	60 days post-enrollment
Weight z-score (WAZ) adjusted for initial WAZ	60 days after enrolment

Trial Locations

Locations (3)

Princess Marina Hospital; 🇧🇼 Gaborone, Botswana

Scottish Livingstone Hospital; 🇧🇼 Molepolole, Botswana

Bamalete Lutheran Hospital; 🇧🇼 Ramotswa, Botswana