Optimizing the Management of Acute Diarrhoeal Disease
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ClinicalTrials.gov Identifier: NCT02803827 |
Recruitment Status :
Completed
First Posted : June 17, 2016
Last Update Posted : February 26, 2019
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Condition or disease | Intervention/treatment | Phase |
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Acute Gastroenteritis | Other: Rapid diagnostics Biological: Probiotic Other: Placebo | Phase 3 |
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 |

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.
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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.
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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.
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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.
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Other: Placebo
The placebo will be the vegetable oil vehicle and look identical to the probiotic. |
- Height z-score (HAZ) adjusted for baseline HAZ [ Time Frame: 60 days post-enrollment ]
- 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 ]

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

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
Botswana | |
Princess Marina Hospital | |
Gaborone, Botswana | |
Deborah Retief Hospital | |
Mochudi, Botswana | |
Scottish Livingstone Hospital | |
Molepolole, Botswana | |
Bamalete Lutheran Hospital | |
Ramotswa, Botswana |
Principal Investigator: | Jeffrey Pernica, MD | McMaster University |
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 |
diarrhoea gastroenteritis rapid diagnostics probiotics |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |