Symprove (Probiotic) as an add-on to COVID-19 Management
NCT ID: NCT04877704
Last Updated: 2021-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-05-31
2022-04-30
Brief Summary
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COVID-19 is a multi-systemic disease in which different mechanisms within the body are affected; including the 'Gut microbiome'. 'Gut microbiome' refers to the bacteria living in intestines. While some bacteria is harmful, many are extremely beneficial and necessary for a healthy body. Many patients have gastrointestinal symptoms and there is a major change in the gut micro flora (microbiome), which may have an adverse effect on the respiratory symptoms. The probiotic, Sivomix, was given to hospitalized COVID-19 patients was associated with a more rapid recovery in gastrointestinal symptoms on day 3 and 7, and an eight fold reduction in the requirement for mechanical ventilation in an open trial.
This is a randomized clinical trial, with a recruitment target of 60 patients admitted with COVID-19 symptoms to the general medical wards. Patients will be randomized to receive the probiotic, Symprove, or placebo in addition to their standard of care treatment. Patients will need take either probiotic/placebo daily for 3 months. All follow-up will be whilst they are an inpatient or as a telephone follow-up; they will not need to attend at the hospital to participate.
There is a biological sub-study incorporated into the protocol, but participation is optional. If patients consent to this, they will also need to provide blood, faecal and saliva samples at baseline, Day 7 and final visit (3 months after randomisation). Patients who consent to providing biological samples will need to visit the hospital at Day 7 and final visit.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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Symprove
Symprove probiotic
Symprove (probiotic)
Symprove's unique water-based formula is packed full of live, active bacteria. It is a probiotic, not a drug.
Placebo
Matched placebo provided by Symprove. Identical in appearance to Symprove probiotic.
Placebo
Matched placebo to Symprove probiotic
Interventions
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Symprove (probiotic)
Symprove's unique water-based formula is packed full of live, active bacteria. It is a probiotic, not a drug.
Placebo
Matched placebo to Symprove probiotic
Eligibility Criteria
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Inclusion Criteria
* Ability to give informed consent
* Aged 20-85
* Inability to consent
* Pregnancy
* Severe pre-existing mental health disorders or addictions
18 Years
85 Years
ALL
No
Sponsors
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King's College Hospital NHS Trust
OTHER
Responsible Party
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Locations
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Institute of Liver Studies
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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290407
Identifier Type: -
Identifier Source: org_study_id
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