Novel Diagnostics and Probiotics to Improve Management of Paediatric Acute Gastroenteritis

Acute Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025452
• Other study ID #: HHS 13-749
• Status: Completed
• Phase: Phase 4
• First received: December 28, 2013
• Last updated: March 23, 2017
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2017
• 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 60 Months

Eligibility

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

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Gastroenteritis

Intervention

Other:
• Rapid diagnostic
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.

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

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

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Jeffrey Pernica	BioGaia AB, Grand Challenges Canada

Country where clinical trial is conducted

Botswana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Height z-score (HAZ) adjusted for initial HAZ		60 days post-enrollment
Secondary	mortality		60 days post-enrollment
Secondary	environmental enteropathy score		60 days post-enrollment
Secondary	duration of diarrhoea	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.	estimated average duration ~ 4 days.
Secondary	Weight z-score (WAZ) adjusted for initial WAZ		60 days after enrolment