NCT02025452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 1, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

8 months

First QC Date

December 28, 2013

Last Update Submit

March 23, 2017

Conditions

Acute Gastroenteritis

Keywords

diarrhoeagastroenteritisrapid diagnosticsprobioticssub-Saharan Africa

Outcome Measures

Primary Outcomes (1)

  • Height z-score (HAZ) adjusted for initial HAZ

    60 days post-enrollment

Secondary Outcomes (4)

  • mortality

    60 days post-enrollment

  • environmental enteropathy score

    60 days post-enrollment

  • duration of diarrhoea

    estimated average duration ~ 4 days.

  • Weight z-score (WAZ) adjusted for initial WAZ

    60 days after enrolment

Study Arms (4)

Rapid diagnostics and probiotic

ACTIVE COMPARATOR
Other: Rapid diagnosticDietary Supplement: Probiotic

Rapid diagnostics and placebo

PLACEBO COMPARATOR
Other: Rapid diagnosticOther: Placebo

Delayed diagnostics and probiotic

EXPERIMENTAL
Dietary Supplement: Probiotic

Delayed diagnostics and placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Rapid diagnosticOTHER

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.

Rapid diagnostics and placeboRapid diagnostics and probiotic
ProbioticDIETARY_SUPPLEMENT

Lactobacillus reuteri suspended in vegetable oil, 5 drops/day (1 x 10e8 CFU) x 2 months

Delayed diagnostics and probioticRapid diagnostics and probiotic
PlaceboOTHER

Identical in appearance to L. reuteri probiotic (same bottle), but simply vegetable oil. Dose is 5 drops/day x 2 months.

Delayed diagnostics and placeboRapid diagnostics and placebo

Eligibility Criteria

Age2 Months - 60 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • acute non-bloody gastroenteritis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Princess Marina Hospital

Gaborone, Botswana

Location

Scottish Livingstone Hospital

Molepolole, Botswana

Location

Bamalete Lutheran Hospital

Ramotswa, Botswana

Location

MeSH Terms

Conditions

DiarrheaGastroenteritis

Interventions

Rapid Diagnostic TestsProbiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesPoint-of-Care TestingPoint-of-Care SystemsPatient Care ManagementHealth Services AdministrationDietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jeffrey Pernica, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head, Division of Pediatric Infectious Disease

Study Record Dates

First Submitted

December 28, 2013

First Posted

January 1, 2014

Study Start

March 1, 2014

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

BO(3)