Novel Diagnostics and Probiotics to Improve Management of Paediatric Acute Gastroenteritis

Rapid Diagnostics and Probiotic Therapy for Paediatric Acute Gastroenteritis - a Randomized, Factorial, Controlled, Placebo-controlled, Pilot Trial

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 Overview

• Status: Completed
• Conditions: Acute Gastroenteritis
• Intervention / Treatment: Other: Rapid diagnostic; Dietary supplement: Probiotic; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 4

Contacts and Locations

Study Locations

• Botswana
  • Gaborone, Botswana
    • Princess Marina Hospital
  • Molepolole, Botswana
    • Scottish Livingstone Hospital
  • Ramotswa, Botswana
    • Bamalete Lutheran Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rapid diagnostics and probiotic	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
Placebo Comparator: Rapid diagnostics and placebo	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.; Other: Placebo; Identical in appearance to L. reuteri probiotic (same bottle), but simply vegetable oil. Dose is 5 drops/day x 2 months.
Experimental: Delayed diagnostics and probiotic	Dietary supplement: Probiotic; Lactobacillus reuteri suspended in vegetable oil, 5 drops/day (1 x 10e8 CFU) x 2 months
Placebo Comparator: Delayed diagnostics and placebo	Other: Placebo; Identical in appearance to L. reuteri probiotic (same bottle), but simply vegetable oil. Dose is 5 drops/day x 2 months.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality		60 days post-enrollment
environmental enteropathy score		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.	estimated average duration ~ 4 days.
Weight z-score (WAZ) adjusted for initial WAZ		60 days after enrolment

Collaborators and Investigators

• Sponsor: Jeffrey Pernica
• Collaborators: Grand Challenges Canada; BioGaia AB
• Investigators: Principal Investigator: Jeffrey Pernica, MD, McMaster University

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 28, 2013
• First Submitted That Met QC Criteria: December 31, 2013
• First Posted (Estimate): January 1, 2014

Study Record Updates

• Last Update Posted (Actual): March 27, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: probiotics; sub-Saharan Africa; diarrhoea; gastroenteritis; rapid diagnostics
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: HHS 13-749