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| Name | Class |
|---|---|
| Grand Challenges Canada | OTHER |
| BioGaia AB | INDUSTRY |
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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. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid diagnostics and probiotic | Active Comparator |
| |
| Rapid diagnostics and placebo | Placebo Comparator |
| |
| Delayed diagnostics and probiotic | Experimental |
| |
| Delayed diagnostics and placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid diagnostic | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Height z-score (HAZ) adjusted for initial HAZ | 60 days post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| mortality | 60 days post-enrollment | |
| environmental enteropathy score | 60 days post-enrollment | |
| duration of diarrhoea |
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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 | ||||
| Scottish Livingstone Hospital |
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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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|
| Probiotic | Dietary Supplement | Lactobacillus reuteri suspended in vegetable oil, 5 drops/day (1 x 10e8 CFU) x 2 months |
|
| Placebo | Other | Identical in appearance to L. reuteri probiotic (same bottle), but simply vegetable oil. Dose is 5 drops/day x 2 months. |
|
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. |
| estimated average duration ~ 4 days. |
| Weight z-score (WAZ) adjusted for initial WAZ | 60 days after enrolment |
| Molepolole |
| Botswana |
| Bamalete Lutheran Hospital | Ramotswa | Botswana |
| 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 |