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Optimizing the Management of Acute Diarrhoeal Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02803827
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
Grand Challenges Canada
BioMérieux
BioGaia AB
Copan Italia S.A.
Botswana-UPenn Partnership
University of British Columbia
Information provided by (Responsible Party):
Jeffrey Pernica, McMaster University

Tracking Information
First Submitted Date  ICMJE June 14, 2016
First Posted Date  ICMJE June 17, 2016
Last Update Posted Date February 26, 2019
Study Start Date  ICMJE June 2016
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2016)
Height z-score (HAZ) adjusted for baseline HAZ [ Time Frame: 60 days post-enrollment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2016)
  • Mortality [ Time Frame: 60 days post-enrollment ]
  • Weight z-score (WAZ) adjusted for baseline WAZ [ Time Frame: 60 days post-enrollment ]
  • Environmental enteropathy score (EES) [ Time Frame: 60 days ]
    composite of stool neopterin, myeloperoxidase, and alpha-1-antitrypsin
  • Diarrhoea recurrence [ Time Frame: 60 days after enrolment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimizing the Management of Acute Diarrhoeal Disease
Official Title  ICMJE Optimizing the Management of Pediatric Acute Diarrhoeal Disease in Botswana
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. The investigators will conduct a randomized trial to see if rapid testing using novel methods to identify potentially treatable causes of diarrhoea leads to improved outcomes. The investigators will also be randomizing children to Lactobacillus reuteri DSM (daughter strain) 17938 therapy versus placebo (the standard of care) to see if this treatment decreases the duration of diarrhoea. The proposed study is a large multi-centre trial following the previous pilot trial.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Gastroenteritis
Intervention  ICMJE
  • Other: Rapid diagnostics
    Participants will have enteric specimens obtained using a flocked rectal swab, which will be transported in 2 mL Cary Blair medium. These will be tested using the BioMerieux BioFire FilmArray GI panel.
  • Biological: Probiotic
    The probiotic given will be Lactobacillus reuteri DSM 17938, 5x10e8 cfu/mL x 60 days, suspended in vegetable oil.
  • Other: Placebo
    The placebo will be the vegetable oil vehicle and look identical to the probiotic.
Study Arms  ICMJE
  • Experimental: Rapid diagnostics and probiotic
    Participants randomized to this arm will have rapid enteric diagnostics performed on the day of enrolment. Those found to have a treatable pathogen will be prescribed antimicrobials that day. Participants will also be given Lactobacillus reuteri DSM 17938 5 x 10e8 cfu/mL x 60 days.
    Interventions:
    • Other: Rapid diagnostics
    • Biological: Probiotic
  • Rapid diagnostics and placebo
    Participants randomized to this arm will have rapid enteric diagnostics performed on the day of enrolment. Those found to have a treatable pathogen will be prescribed antimicrobials that day. Participants will also be given placebo x 60 days.
    Interventions:
    • Other: Rapid diagnostics
    • Other: Placebo
  • No rapid diagnostics and probiotic
    Participants randomized to this arm will have stool specimens processed after the conclusion of the study. Participants will also be given Lactobacillus reuteri DSM 17938 5 x 10e8 cfu/mL x 60 days.
    Intervention: Biological: Probiotic
  • Placebo Comparator: No rapid diagnostics and placebo
    Participants randomized to this arm will have stool specimens processed after the conclusion of the study. Participants will also be given placebo x 60 days.
    Intervention: Other: Placebo
Publications * Pernica JM, Arscott-Mills T, Steenhoff AP, Mokomane M, Moorad B, Bapabi M, Lechiile K, Mangwegape O, Batisani B, Mawoko N, Muthoga C, Vanniyasingam T, Ewusie J, Lowe A, Bonsu JM, Gezmu AM, Smieja M, Mazhani L, Stordal K, Thabane L, Kelly MS, Goldfarb DM. Optimising the management of childhood acute diarrhoeal disease using a rapid test-and- treat strategy and/or Lactobacillus reuteri DSM 17938: a multicentre, randomised, controlled, factorial trial in Botswana. BMJ Glob Health. 2022 Apr;7(4). pii: e007826. doi: 10.1136/bmjgh-2021-007826.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2019)
276
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2016)
400
Actual Study Completion Date  ICMJE February 2019
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • acute diarrhoeal illness (>= 3 stools in 24 hour period)

Exclusion Criteria:

  • diarrhoeal illness >=14 days
  • bloody stool
  • known inflammatory bowel disease, cystic fibrosis, or malignancy
  • live in a household with someone else documented to have a bacterial or parasitic enteric infection of defined aetiology
  • live outside catchment areas
  • no permanent address
  • no access to mobile phone
  • previous participation in this study
  • nosocomial diarrhoea
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 60 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Botswana
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02803827
Other Study ID Numbers  ICMJE GCC 0768-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jeffrey Pernica, McMaster University
Original Responsible Party Hamilton Health Sciences Corporation
Current Study Sponsor  ICMJE Hamilton Health Sciences Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Grand Challenges Canada
  • BioMérieux
  • BioGaia AB
  • Copan Italia S.A.
  • Botswana-UPenn Partnership
  • University of British Columbia
Investigators  ICMJE
Principal Investigator: Jeffrey Pernica, MD McMaster University
PRS Account Hamilton Health Sciences Corporation
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP