Novel Diagnostics and Probiotics to Improve Management of Paediatric Acute Gastroenteritis

Jeffrey Pernica

Status and phase: Completed; Phase 4

Conditions: Acute Gastroenteritis

Treatments: Other: Placebo; Other: Rapid diagnostic; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02025452

HHS 13-749

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 2 to 60 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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76 participants in 4 patient groups, including a placebo group

Rapid diagnostics and probiotic

Active Comparator group

Treatment:

Other: Rapid diagnostic

Dietary Supplement: Probiotic

Rapid diagnostics and placebo

Placebo Comparator group

Treatment:

Other: Rapid diagnostic

Other: Placebo

Delayed diagnostics and probiotic

Experimental group

Treatment:

Dietary Supplement: Probiotic

Delayed diagnostics and placebo

Placebo Comparator group

Treatment:

Other: Placebo