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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

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.

Condition or disease Intervention/treatment Phase
Acute Gastroenteritis Other: Rapid diagnostics Biological: Probiotic Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing the Management of Pediatric Acute Diarrhoeal Disease in Botswana
Study Start Date : June 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis

Arm Intervention/treatment
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.
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.

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.
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.

Other: Placebo
The placebo will be the vegetable oil vehicle and look identical to the probiotic.

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.
Biological: Probiotic
The probiotic given will be Lactobacillus reuteri DSM 17938, 5x10e8 cfu/mL x 60 days, suspended in vegetable oil.

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.
Other: Placebo
The placebo will be the vegetable oil vehicle and look identical to the probiotic.




Primary Outcome Measures :
  1. Height z-score (HAZ) adjusted for baseline HAZ [ Time Frame: 60 days post-enrollment ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 60 days post-enrollment ]
  2. Weight z-score (WAZ) adjusted for baseline WAZ [ Time Frame: 60 days post-enrollment ]
  3. Environmental enteropathy score (EES) [ Time Frame: 60 days ]
    composite of stool neopterin, myeloperoxidase, and alpha-1-antitrypsin

  4. Diarrhoea recurrence [ Time Frame: 60 days after enrolment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02803827


Locations
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Botswana
Princess Marina Hospital
Gaborone, Botswana
Deborah Retief Hospital
Mochudi, Botswana
Scottish Livingstone Hospital
Molepolole, Botswana
Bamalete Lutheran Hospital
Ramotswa, Botswana
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Grand Challenges Canada
BioMérieux
BioGaia AB
Copan Italia S.A.
Botswana-UPenn Partnership
University of British Columbia
Investigators
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Principal Investigator: Jeffrey Pernica, MD McMaster University

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Responsible Party: Jeffrey Pernica, Head, Division of Infectious Diseases, McMaster University
ClinicalTrials.gov Identifier: NCT02803827    
Other Study ID Numbers: GCC 0768-05
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Keywords provided by Jeffrey Pernica, McMaster University:
diarrhoea
gastroenteritis
rapid diagnostics
probiotics
Additional relevant MeSH terms:
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Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases