Novel Diagnostics and Probiotics to Improve Management of Paediatric Acute Gastroenteritis

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.

Full Title of Study: “Rapid Diagnostics and Probiotic Therapy for Paediatric Acute Gastroenteritis – a Randomized, Factorial, Controlled, Placebo-controlled, Pilot Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2014

Interventions

  • Other: Rapid diagnostic
    • 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.
  • Dietary Supplement: Probiotic
    • Lactobacillus reuteri suspended in vegetable oil, 5 drops/day (1 x 10e8 CFU) x 2 months
  • Other: Placebo
    • Identical in appearance to L. reuteri probiotic (same bottle), but simply vegetable oil. Dose is 5 drops/day x 2 months.

Arms, Groups and Cohorts

  • Active Comparator: Rapid diagnostics and probiotic
  • Placebo Comparator: Rapid diagnostics and placebo
  • Experimental: Delayed diagnostics and probiotic
  • Placebo Comparator: Delayed diagnostics and placebo

Clinical Trial Outcome Measures

Primary Measures

  • Height z-score (HAZ) adjusted for initial HAZ
    • Time Frame: 60 days post-enrollment

Secondary Measures

  • mortality
    • Time Frame: 60 days post-enrollment
  • environmental enteropathy score
    • Time Frame: 60 days post-enrollment
  • duration of diarrhoea
    • Time Frame: 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.
  • Weight z-score (WAZ) adjusted for initial WAZ
    • Time Frame: 60 days after enrolment

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Months

Maximum Age: 60 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jeffrey Pernica
  • Collaborator
    • Grand Challenges Canada
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jeffrey Pernica, Head, Division of Pediatric Infectious Disease – Hamilton Health Sciences Corporation
  • Overall Official(s)
    • Jeffrey Pernica, MD, Principal Investigator, McMaster University

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