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| Name | Class |
|---|---|
| Grand Challenges Canada | OTHER |
| BioMérieux | INDUSTRY |
| BioGaia AB | INDUSTRY |
| Copan Italia S.A. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid diagnostics and probiotic | Experimental | 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. |
|
| Rapid diagnostics and placebo | Other | 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. |
|
| No rapid diagnostics and probiotic | Other | 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. |
|
| No rapid diagnostics and placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid diagnostics | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Height z-score (HAZ) adjusted for baseline HAZ | 60 days post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 60 days post-enrollment | |
| Weight z-score (WAZ) adjusted for baseline WAZ | 60 days post-enrollment | |
| Environmental enteropathy score (EES) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Pernica, MD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Marina Hospital | Gaborone | Botswana | ||||
| Deborah Retief Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39052715 | Derived | Guitor AK, Katyukhina A, Mokomane M, Lechiile K, Goldfarb DM, Wright GD, McArthur AG, Pernica JM. Minimal Impact on the Resistome of Children in Botswana After Azithromycin Treatment for Acute Severe Diarrheal Disease. J Infect Dis. 2024 Jul 25;230(1):239-249. doi: 10.1093/infdis/jiae049. | |
| 35418412 | Derived |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D005759 | Gastroenteritis |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000092025 | Rapid Diagnostic Tests |
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| UNKNOWN |
| Botswana-UPenn Partnership | OTHER |
| University of British Columbia | OTHER |
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| Probiotic | Biological | The probiotic given will be Lactobacillus reuteri DSM 17938, 5x10e8 cfu/mL x 60 days, suspended in vegetable oil. |
|
| Placebo | Other | The placebo will be the vegetable oil vehicle and look identical to the probiotic. |
|
composite of stool neopterin, myeloperoxidase, and alpha-1-antitrypsin |
| 60 days |
| Diarrhoea recurrence | 60 days after enrolment |
| Mochudi |
| Botswana |
| Scottish Livingstone Hospital | Molepolole | Botswana |
| Bamalete Lutheran Hospital | Ramotswa | Botswana |
| 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):e007826. doi: 10.1136/bmjgh-2021-007826. |
| D004066 | Digestive System Diseases |
| D000067716 | Point-of-Care Testing |
| D019095 | Point-of-Care Systems |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |