Acute GastroenteritisPhase 4NCT02025452
Novel Diagnostics and Probiotics to Improve Management of Paediatric Acute Gastroenteritis
A Phase 4 study testing Rapid diagnostic and Probiotic in people with Acute Gastroenteritis, run by Jeffrey Pernica at 3 sites in Botswana.
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. Read more about this study
- Who is it for?
- Ages 2 to 60 months
- Conditions the study is for
- Acute Gastroenteritis
- What is being tested?
- Rapid diagnostic and Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 3 sitesBotswana
- Study dates
- Mar 2014to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- acute non-bloody gastroenteritis
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Botswana3 sites
Princess Marina Hospital
Gaborone
Scottish Livingstone Hospital
Molepolole
Bamalete Lutheran Hospital
Ramotswa
About this study
Official title: Rapid Diagnostics and Probiotic Therapy for Paediatric Acute Gastroenteritis - a Randomized, Factorial, Controlled, Placebo-controlled, Pilot Trial
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.
- Conditions
- Acute Gastroenteritis
- Being tested
- Rapid diagnostic, Probiotic, Placebo
- Keywords
- diarrhoea, gastroenteritis, rapid diagnostics, probiotics, sub-Saharan Africa
- Medical subject headings
- Diarrhea, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid diagnosticOther
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.
ProbioticDietary supplement
Lactobacillus reuteri suspended in vegetable oil, 5 drops/day (1 x 10e8 CFU) x 2 months
PlaceboOther
Identical in appearance to L. reuteri probiotic (same bottle), but simply vegetable oil. Dose is 5 drops/day x 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Rapid diagnostics and probiotic | Active comparator | Not described Receives: Other: Rapid diagnostic; Dietary Supplement: Probiotic |
| Rapid diagnostics and placebo | Placebo comparator | Not described Receives: Other: Rapid diagnostic; Other: Placebo |
| Delayed diagnostics and probiotic | Experimental | Not described Receives: Dietary Supplement: Probiotic |
| Delayed diagnostics and placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height z-score (HAZ) adjusted for initial HAZ
Measured: 60 days post-enrollment
Secondary outcomes (4)
mortality
Measured: 60 days post-enrollment
environmental enteropathy score
Measured: 60 days post-enrollment
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.
Measured: estimated average duration ~ 4 days.
Weight z-score (WAZ) adjusted for initial WAZ
Measured: 60 days after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute GastroenteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeffrey Pernica
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada, BioGaia AB
- Responsible party
- Sponsor-investigator, Jeffrey Pernica, Hamilton Health Sciences Corporation
- Investigators
- Jeffrey Pernica, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025452
- Sponsor's protocol ID
- HHS 13-749
- Status last verified
- Mar 2017
- First submitted
- 28 Dec 2013
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Diagnostics and Probiotic Therapy for Paediatric Acute Gastroenteritis - a Randomized, Factorial, Controlled, Placebo-controlled, Pilot Trial
- ClinicalTrials.gov ID
- NCT02025452
- Acronym / sponsor ID
- HHS 13-749
- Conditions
- Acute Gastroenteritis
- Keywords
- diarrhoea, gastroenteritis, rapid diagnostics, probiotics, sub-Saharan Africa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Jeffrey PernicaUniversity, hospital or other
- Collaborators
- Grand Challenges Canada, BioGaia AB
- Study start
- Mar 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Rapid diagnostics and probiotic | Active comparator | Other: Rapid diagnostic, Dietary Supplement: Probiotic |
| Rapid diagnostics and placebo | Placebo comparator | Other: Rapid diagnostic, Other: Placebo |
| Delayed diagnostics and probiotic | Experimental | Dietary Supplement: Probiotic |
| Delayed diagnostics and placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 2 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- acute non-bloody gastroenteritis
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid diagnosticSpecimens 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. | Other | Rapid diagnostics and placebo, Rapid diagnostics and probiotic |
| ProbioticLactobacillus reuteri suspended in vegetable oil, 5 drops/day (1 x 10e8 CFU) x 2 months | Dietary supplement | Delayed diagnostics and probiotic, Rapid diagnostics and probiotic |
| PlaceboIdentical in appearance to L. reuteri probiotic (same bottle), but simply vegetable oil. Dose is 5 drops/day x 2 months. | Other | Delayed diagnostics and placebo, Rapid diagnostics and placebo |
Primary outcome
Height z-score (HAZ) adjusted for initial HAZ
Time frame: 60 days post-enrollment
4 secondary outcomes
mortality
Time frame: 60 days post-enrollment
environmental enteropathy score
Time frame: 60 days post-enrollment
duration of diarrhoea
Time frame: estimated average duration ~ 4 days.
Weight z-score (WAZ) adjusted for initial WAZ
Time frame: 60 days after enrolment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Pernica, MD principal investigator
McMaster University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rapid diagnostic and Probiotic in people with Acute Gastroenteritis, run by Jeffrey Pernica at 3 sites in Botswana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height z-score (HAZ) adjusted for initial HAZ (time frame: 60 days post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.