Novel Diagnostics and Probiotics to Improve Management of Paediatric Acute Gastroenteritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Hamilton Health Sciences Corporation
Sponsor:
Collaborators:
Grand Challenges Canada
BioGaia AB
Information provided by (Responsible Party):
Jeffrey Pernica, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier:
NCT02025452
First received: December 28, 2013
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Acute Gastroenteritis
Other: Rapid diagnostic
Dietary Supplement: Probiotic
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Hamilton Health Sciences Corporation:

Primary Outcome Measures:
  • mortality [ Time Frame: 60 days post-enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Height z-score (HAZ) adjusted for initial HAZ [ Time Frame: 60 days post-enrollment ] [ Designated as safety issue: No ]
  • environmental enteropathy score [ Time Frame: 60 days post-enrollment ] [ Designated as safety issue: No ]
  • duration of diarrhoea [ Time Frame: estimated average duration ~ 4 days. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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, 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.
Experimental: Delayed diagnostics and probiotic Dietary Supplement: Probiotic
Lactobacillus reuteri, 5 drops/day (1 x 10e8 CFU) x 2 months
Placebo Comparator: Delayed diagnostics and placebo

  Eligibility

Ages Eligible for Study:   3 Months to 60 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • acute non-bloody gastroenteritis

Exclusion Criteria:

  • diarrhoea > 14 days
  • sepsis, pneumonia, UTI, meningitis, severe metabolic acidosis 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02025452

Locations
Botswana
Princess Marina Hospital Recruiting
Gaborone, Botswana
Contact: Andrew Steenhoff, MBBS, MSc    (267) 317 0957    steenhoff@email.chop.edu   
Principal Investigator: Andrew Steenhoff, MBBS, MSc         
Sponsors and Collaborators
Jeffrey Pernica
Grand Challenges Canada
BioGaia AB
Investigators
Principal Investigator: Jeffrey Pernica, MD McMaster University
  More Information

No publications provided

Responsible Party: Jeffrey Pernica, Head, Division of Pediatric Infectious Disease, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT02025452     History of Changes
Other Study ID Numbers: HHS 13-749
Study First Received: December 28, 2013
Last Updated: March 12, 2014
Health Authority: Canada: Health Canada

Keywords provided by Hamilton Health Sciences Corporation:
diarrhoea
gastroenteritis
rapid diagnostics
probiotics
sub-Saharan Africa

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014