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Acute GastroenteritisPhase 3NCT02803827

Optimizing the Management of Acute Diarrhoeal Disease

A Phase 3 study testing Rapid diagnostics and Probiotic in people with Acute Gastroenteritis, run by Hamilton Health Sciences Corporation at 4 sites in Botswana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 diagnostics and Probiotic
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
276 participants
Where
4 sitesBotswana
Study dates
Jun 2016to Feb 2019
Phase
Phase 3
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 diarrhoeal illness (>= 3 stools in 24 hour period)

Who cannot join

  • 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
Show all 9Show fewer
  • no access to mobile phone
  • previous participation in this study
  • nosocomial diarrhoea

Trial locations and contacts

4 sites in 1 country.

Botswana4 sites

  • Princess Marina Hospital

    Gaborone

  • Deborah Retief Hospital

    Mochudi

  • Scottish Livingstone Hospital

    Molepolole

  • Bamalete Lutheran Hospital

    Ramotswa

Other trials in Botswana

About this study

Official title: Optimizing the Management of Pediatric Acute Diarrhoeal Disease in Botswana

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.

Being tested
Rapid diagnostics, Probiotic, Placebo
Keywords
diarrhoea, gastroenteritis, rapid diagnostics, probiotics
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 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.

  • ProbioticBiological

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

  • PlaceboOther

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

Study groups in NCT02803827
Study groupRoleWhat they receive
Rapid diagnostics and probioticExperimentalParticipants 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.
Receives: Other: Rapid diagnostics; Biological: Probiotic
Rapid diagnostics and placeboOtherParticipants 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.
Receives: Other: Rapid diagnostics; Other: Placebo
No rapid diagnostics and probioticOtherParticipants 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.
Receives: Biological: Probiotic
No rapid diagnostics and placeboPlacebo comparatorParticipants randomized to this arm will have stool specimens processed after the conclusion of the study. Participants will also be given placebo x 60 days.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 60 days post-enrollment

Secondary outcomes (4)

  1. Mortality

    Measured: 60 days post-enrollment

  2. Weight z-score (WAZ) adjusted for baseline WAZ

    Measured: 60 days post-enrollment

  3. Environmental enteropathy score (EES)

    composite of stool neopterin, myeloperoxidase, and alpha-1-antitrypsin

    Measured: 60 days

  4. Diarrhoea recurrence

    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.

  1. First posted17 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJan 2019
  4. Study completionFeb 2019

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02803827
Sponsor's protocol ID
GCC 0768-05
Status last verified
Feb 2019
First submitted
14 Jun 2016
Last updated
26 Feb 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 39052715

  • 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.

    PubMed 35418412

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rapid diagnostics and Probiotic in people with Acute Gastroenteritis, run by Hamilton Health Sciences Corporation at 4 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 9 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 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 baseline 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?

On the ClinicalTrials.gov record for NCT02803827, which also lists 2 linked publications.

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 26 Feb 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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