Novel Diagnostics and Probiotics to Improve Management of Paediatric Acute Gastroenteritis

Sponsor

Jeffrey Pernica (Other)

Overall Status

Completed

CT.gov ID

NCT02025452

Collaborator

Grand Challenges Canada (Other), BioGaia AB (Industry)

Enrollment

Locations

Arms

Duration (Months)

25.3

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Gastroenteritis	Other: Rapid diagnostic Dietary Supplement: Probiotic Other: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Height z-score (HAZ) adjusted for initial HAZ [60 days post-enrollment]

Secondary Outcome Measures

mortality [60 days post-enrollment]
environmental enteropathy score [60 days post-enrollment]
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.
Weight z-score (WAZ) adjusted for initial WAZ [60 days after enrolment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 60 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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