NCT02803827

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2016

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

2.6 years

First QC Date

June 14, 2016

Last Update Submit

February 23, 2019

Conditions

Acute Gastroenteritis

Keywords

diarrhoeagastroenteritisrapid diagnosticsprobiotics

Outcome Measures

Primary Outcomes (1)

  • Height z-score (HAZ) adjusted for baseline HAZ

    60 days post-enrollment

Secondary Outcomes (4)

  • Mortality

    60 days post-enrollment

  • Weight z-score (WAZ) adjusted for baseline WAZ

    60 days post-enrollment

  • Environmental enteropathy score (EES)

    60 days

  • Diarrhoea recurrence

    60 days after enrolment

Study Arms (4)

Rapid diagnostics and probiotic

EXPERIMENTAL

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.

Other: Rapid diagnosticsBiological: Probiotic

Rapid diagnostics and placebo

OTHER

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.

Other: Rapid diagnosticsOther: Placebo

No rapid diagnostics and probiotic

OTHER

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.

Biological: Probiotic

No rapid diagnostics and placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Rapid diagnosticsOTHER

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.

Rapid diagnostics and placeboRapid diagnostics and probiotic
ProbioticBIOLOGICAL

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

No rapid diagnostics and probioticRapid diagnostics and probiotic
PlaceboOTHER

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

No rapid diagnostics and placeboRapid diagnostics and placebo

Eligibility Criteria

Age2 Months - 60 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • acute diarrhoeal illness (\>= 3 stools in 24 hour period)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Princess Marina Hospital

Gaborone, Botswana

Location

Deborah Retief Hospital

Mochudi, Botswana

Location

Scottish Livingstone Hospital

Molepolole, Botswana

Location

Bamalete Lutheran Hospital

Ramotswa, Botswana

Location

Related Publications (2)

  • Guitor AK, Katyukhina A, Mokomane M, Lechiile K, Goldfarb DM, Wright GD, McArthur AG, Pernica JM. Minimal Impact on the Resistome of Children in Botswana After Azithromycin Treatment for Acute Severe Diarrheal Disease. J Infect Dis. 2024 Jul 25;230(1):239-249. doi: 10.1093/infdis/jiae049.

    PMID: 39052715DERIVED

  • Pernica JM, Arscott-Mills T, Steenhoff AP, Mokomane M, Moorad B, Bapabi M, Lechiile K, Mangwegape O, Batisani B, Mawoko N, Muthoga C, Vanniyasingam T, Ewusie J, Lowe A, Bonsu JM, Gezmu AM, Smieja M, Mazhani L, Stordal K, Thabane L, Kelly MS, Goldfarb DM. Optimising the management of childhood acute diarrhoeal disease using a rapid test-and- treat strategy and/or Lactobacillus reuteri DSM 17938: a multicentre, randomised, controlled, factorial trial in Botswana. BMJ Glob Health. 2022 Apr;7(4):e007826. doi: 10.1136/bmjgh-2021-007826.

    PMID: 35418412DERIVED

MeSH Terms

Conditions

DiarrheaGastroenteritis

Interventions

Rapid Diagnostic TestsProbiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesPoint-of-Care TestingPoint-of-Care SystemsPatient Care ManagementHealth Services AdministrationDietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jeffrey Pernica, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Division of Infectious Diseases

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 17, 2016

Study Start

June 1, 2016

Primary Completion

January 1, 2019

Study Completion

February 1, 2019

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

BO(4)