Optimizing the Management of Acute Diarrhoeal Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Acute Gastroenteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Rapid diagnostics

Intervention Type 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.

Probiotic

Intervention Type BIOLOGICAL

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.

Group Type OTHER

Rapid diagnostics

Intervention Type 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.

Placebo

Intervention Type OTHER

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.

Group Type OTHER

Probiotic

Intervention Type BIOLOGICAL

The probiotic given will be Lactobacillus reuteri DSM 17938, 5x10e8 cfu/mL x 60 days, suspended in vegetable oil.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Probiotic

The probiotic given will be Lactobacillus reuteri DSM 17938, 5x10e8 cfu/mL x 60 days, suspended in vegetable oil.

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

2 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No