Symprove (Probiotic) as an add-on to COVID-19 Management

Covid19 Clinical Trial

Official title:

The Effect of Symprove, a Multi-strain Probiotic, as an Adjuvant in the Management of COVID-19 in Hospitalized Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04877704
• Other study ID #: 290407
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 31, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2021
• Source: King's College Hospital NHS Trust
• Contact: Bu'Hussain Hayee, BSc, MBBS, FRCP, PhD
• Phone: 02032998848
• Email: b.hayee[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Symptomatic patients who are hospitalised with respiratory COVID-19

• Ability to give informed consent

• Aged 20-85

Exclusion Criteria:

• Patients not meeting the inclusion criteria that have COVID-19

• Inability to consent

• Pregnancy

• Severe pre-existing mental health disorders or addictions

Related Conditions & MeSH terms

• Covid19

Intervention

Other:
• 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

Locations

Country	Name	City	State
United Kingdom	Institute of Liver Studies	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	Clinical symptoms	Whether administration of Symprove is associated with significantly greater improvements in clinical symptoms as opposed to placebo on day 3 and 7.	7 days
Secondary	Intestinal inflammation	Whether Symprove reduced intestinal inflammation as compared with that seen in placebo are improved (at day 7 and 3 months).	3 months
Secondary	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).	3 months