Optimizing the Management of Acute Diarrhoeal Disease

Sponsor

Hamilton Health Sciences Corporation (Other)

Overall Status

Completed

CT.gov ID

NCT02803827

Collaborator

Grand Challenges Canada (Other), BioMérieux (Industry), BioGaia AB (Industry), Copan Italia S.A. (Other), Botswana-UPenn Partnership (Other), University of British Columbia (Other)

276

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Jun 1, 2016

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Feb 1, 2019

Arms and Interventions

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.
Other: 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.
Other: 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.

Outcome Measures

Primary Outcome Measures

Height z-score (HAZ) adjusted for baseline HAZ [60 days post-enrollment]

Secondary Outcome Measures

Mortality [60 days post-enrollment]
Weight z-score (WAZ) adjusted for baseline WAZ [60 days post-enrollment]
Environmental enteropathy score (EES) [60 days]
composite of stool neopterin, myeloperoxidase, and alpha-1-antitrypsin
Diarrhoea recurrence [60 days after enrolment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 60 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Princess Marina Hospital	Gaborone	Botswana
2	Deborah Retief Hospital	Mochudi	Botswana
3	Scottish Livingstone Hospital	Molepolole	Botswana
4	Bamalete Lutheran Hospital	Ramotswa	Botswana