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NCT Number: NCT02803827

Optimizing the Management of Acute Diarrhoeal Disease

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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Key information

Conditions

Acute Gastroenteritis Diarrhea Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

2 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Princess Marina Hospital, Gaborone, Botswana

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid diagnostics

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

Biological

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

Placebo

Other

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

Primary outcomes

  1. Height z-score (HAZ) adjusted for baseline HAZ

    Time frame: 60 days post-enrollment

Secondary outcomes

  1. Mortality

    Time frame: 60 days post-enrollment

  2. Weight z-score (WAZ) adjusted for baseline WAZ

    Time frame: 60 days post-enrollment

  3. Environmental enteropathy score (EES)

    Time frame: 60 days

    composite of stool neopterin, myeloperoxidase, and alpha-1-antitrypsin

  4. Diarrhoea recurrence

    Time frame: 60 days after enrolment

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • BioGaia AB
  • BioMérieux
  • Botswana-UPenn Partnership
  • Copan Italia S.A.
  • Grand Challenges Canada
  • University of British Columbia

Registry information

Official study title

Optimizing the Management of Pediatric Acute Diarrhoeal Disease in Botswana

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 17, 2016
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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