Optimizing the Management of Acute Diarrhoeal Disease

Acute Gastroenteritis Clinical Trial

Official title:

Optimizing the Management of Pediatric Acute Diarrhoeal Disease in Botswana

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803827
• Other study ID #: GCC 0768-05
• Status: Completed
• Phase: Phase 3
• Start date: June 2016
• Est. completion date: February 2019

Study information

• Verified date: February 2019
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: February 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 60 Months

Eligibility

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

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Gastroenteritis

Intervention

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

Locations

Country	Name	City	State
Botswana	Princess Marina Hospital	Gaborone
Botswana	Deborah Retief Hospital	Mochudi
Botswana	Scottish Livingstone Hospital	Molepolole
Botswana	Bamalete Lutheran Hospital	Ramotswa

Sponsors (7)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	BioGaia AB, BioMérieux, Botswana-UPenn Partnership, Copan Italia S.A., Grand Challenges Canada, University of British Columbia

Country where clinical trial is conducted

Botswana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Height z-score (HAZ) adjusted for baseline HAZ		60 days post-enrollment
Secondary	Mortality		60 days post-enrollment
Secondary	Weight z-score (WAZ) adjusted for baseline WAZ		60 days post-enrollment
Secondary	Environmental enteropathy score (EES)	composite of stool neopterin, myeloperoxidase, and alpha-1-antitrypsin	60 days
Secondary	Diarrhoea recurrence		60 days after enrolment