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

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Covid19
• Intervention / Treatment: Other: Symprove (probiotic); Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bu'Hussain Hayee, BSc, MBBS, FRCP, PhD; Phone Number: 02032998848; Email: b.hayee@nhs.net
• Study Contact Backup: Name: Refah Z Ahmed, BA MSc; Phone Number: 02032997150; Email: refah.ahmed1@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Institute of Liver Studies
    • Contact: Bu'Hussain Hayee, BSc, MBBS, FRCP, PhD; Phone Number: 02032998848; Email: b.hayee@nhs.net
    • Contact: Refah Z Ahmed, BA MSc; Phone Number: 02032997150; Email: refah.ahmed1@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Symprove; Symprove probiotic	Other: Symprove (probiotic); Symprove's unique water-based formula is packed full of live, active bacteria. It is a probiotic, not a drug.
Placebo Comparator: Placebo; Matched placebo provided by Symprove. Identical in appearance to Symprove probiotic.	Other: Placebo; Matched placebo to Symprove probiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Intestinal inflammation	Whether Symprove reduced intestinal inflammation as compared with that seen in placebo are improved (at day 7 and 3 months).	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).	3 months

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): May 31, 2021
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 290407

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No