Covid19NCT04877704
Symprove (Probiotic) as an add-on to COVID-19 Management
A study testing Symprove (probiotic) in people with Covid19, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
The major impact of COVID-19 has been that the severity of respiratory symptoms require intensive hospital treatment. There is significant mortality and many of the survivors have a delayed recovery requiring intensive prolonged rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Covid19
- What is being tested?
- Symprove (probiotic)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 May 2021to 30 Apr 2022
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic patients who are hospitalised with respiratory COVID-19
- Ability to give informed consent
- Aged 20-85
Who cannot join
- Patients not meeting the inclusion criteria that have COVID-19
- Inability to consent
- Pregnancy
- Severe pre-existing mental health disorders or addictions
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Liver Studies
London, SE5 9RS
Bu'Hussain Hayee, BSc, MBBS, FRCP, PhD, 02032998848, b.hayee@nhs.net
Refah Z Ahmed, BA MSc, 02032997150, refah.ahmed1@nhs.net
About this study
Official title: The Effect of Symprove, a Multi-strain Probiotic, as an Adjuvant in the Management of COVID-19 in Hospitalized Patients
The major impact of COVID-19 has been that the severity of respiratory symptoms require intensive hospital treatment. There is significant mortality and many of the survivors have a delayed recovery requiring intensive prolonged rehabilitation.
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.
Read more
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.
- Conditions
- Covid19
- Being tested
- Symprove (probiotic), Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symprove (probiotic)Other
Symprove's unique water-based formula is packed full of live, active bacteria. It is a probiotic, not a drug.
PlaceboOther
Matched placebo to Symprove probiotic
| Study group | Role | What they receive |
|---|---|---|
| Symprove | Experimental | Symprove probiotic Receives: Other: Symprove (probiotic) |
| Placebo | Placebo comparator | Matched placebo provided by Symprove. Identical in appearance to Symprove probiotic. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
To assess if taking the probiotic Symprove reduces the length of hospital stay of patients with symptomatic respiratory COVID-19 infection
Measured: 12 months
Secondary outcomes (3)
Clinical symptoms
Whether administration of Symprove is associated with significantly greater improvements in clinical symptoms as opposed to placebo on day 3 and 7.
Measured: 7 days
Intestinal inflammation
Whether Symprove reduced intestinal inflammation as compared with that seen in placebo are improved (at day 7 and 3 months).
Measured: 3 months
Symptom recovery
Whether symptom recovery is more complete with the probiotic 3 months from the onset of the trial (all subjects will receive Symprove or placebo for 3 months).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start31 May 2021 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877704
- Sponsor's protocol ID
- 290407
- Status last verified
- May 2021
- First submitted
- 5 May 2021
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Symprove, a Multi-strain Probiotic, as an Adjuvant in the Management of COVID-19 in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT04877704
- Acronym / sponsor ID
- 290407
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 31 May 2021 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 7 May 2021 (actual)
- 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.
The major impact of COVID-19 has been that the severity of respiratory symptoms require intensive hospital treatment. There is significant mortality and many of the survivors have a delayed recovery requiring intensive prolonged rehabilitation.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symprove | Experimental | Other: Symprove (probiotic)Symprove probiotic |
| Placebo | Placebo comparator | Other: PlaceboMatched placebo provided by Symprove. Identical in appearance to Symprove probiotic. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic patients who are hospitalised with respiratory COVID-19
- Ability to give informed consent
- Aged 20-85
Key exclusion criteria (4 listed)
- Patients not meeting the inclusion criteria that have COVID-19
- Inability to consent
- Pregnancy
- Severe pre-existing mental health disorders or addictions
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 |
|---|---|---|
| Symprove (probiotic)Symprove's unique water-based formula is packed full of live, active bacteria. It is a probiotic, not a drug. | Other | Symprove |
| PlaceboMatched placebo to Symprove probiotic | Other | Placebo |
Primary outcome
Length of hospital stay
Time frame: 12 months
To assess if taking the probiotic Symprove reduces the length of hospital stay of patients with symptomatic respiratory COVID-19 infection
3 secondary outcomes
Clinical symptoms
Time frame: 7 days
Intestinal inflammation
Time frame: 3 months
Symptom recovery
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symprove (probiotic) in people with Covid19, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bu'Hussain Hayee, BSc, MBBS, FRCP, PhD (02032998848, b.hayee@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: 12 months). 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 7 May 2021.