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OpenTrials
Completed

NCT Number: NCT02025452

Novel Diagnostics and Probiotics to Improve Management of Paediatric Acute Gastroenteritis

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. We will conduct a randomized trial to see if rapid testing using novel methods to identify potentially treatable causes of diarrhoea leads to improved outcomes. We will also be randomizing children to probiotic therapy versus placebo (the standard of care) to see if this treatment decreases the duration of diarrhoea. The proposed study is a pilot trial, necessary before embarking on a large multi-centre 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 4

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 non-bloody gastroenteritis

Exclusion criteria

  • diarrhoea > 14 days
  • sepsis, pneumonia, UTI, meningitis requiring empiric antibiotic therapy
  • malignancy, IBD
  • known link to another patient with diarrhoea of defined aetiology
  • transferred in already on antimicrobials
  • live outside study area
  • children with severe acute malnutrition will be eligible for diagnostic arm but not probiotic arm

Treatment and study plan

Rapid diagnostic

Other

Specimens from rectal mucosa will be obtained using flocked swabs at enrolment. Those in 'rapid diagnostic' groups will have them tested using multiplex PCR the day of enrolment and participants with treatable pathogens will have antimicrobials provided. Those in 'delayed diagnostic' groups will have the swabs batched at tested at the conclusion of the study, being treated as per standard of care.

Probiotic

Dietary Supplement

Lactobacillus reuteri suspended in vegetable oil, 5 drops/day (1 x 10e8 CFU) x 2 months

Placebo

Other

Identical in appearance to L. reuteri probiotic (same bottle), but simply vegetable oil. Dose is 5 drops/day x 2 months.

Primary outcomes

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

    Time frame: 60 days post-enrollment

Secondary outcomes

  1. mortality

    Time frame: 60 days post-enrollment

  2. environmental enteropathy score

    Time frame: 60 days post-enrollment

  3. duration of diarrhoea

    Time frame: estimated average duration ~ 4 days.

    Note that presence of diarrhoea will be checked daily during admission. Total duration of diarrhoea will be verified with the caregiver by telephone 7 days after the participant was discharged home.

  4. Weight z-score (WAZ) adjusted for initial WAZ

    Time frame: 60 days after enrolment

Sponsors and collaborators

Lead sponsor

Jeffrey Pernica

Other

Collaborators

  • BioGaia AB
  • Grand Challenges Canada

Registry information

Official study title

Rapid Diagnostics and Probiotic Therapy for Paediatric Acute Gastroenteritis - a Randomized, Factorial, Controlled, Placebo-controlled, Pilot Trial

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 1, 2014
Registry last updated
Mar 27, 2017

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

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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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