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

NCT04877704 | Unknown

• 1 other identifier: 290407
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical symptoms

  7 days

• Intestinal inflammation

  3 months

• Symptom recovery

  3 months

Study Arms (2)

Symprove

EXPERIMENTAL

Symprove probiotic

Other: Symprove (probiotic)

Placebo

PLACEBO COMPARATOR

Matched placebo provided by Symprove. Identical in appearance to Symprove probiotic.

Other: Placebo

Interventions

Symprove (probiotic) OTHER

Symprove's unique water-based formula is packed full of live, active bacteria. It is a probiotic, not a drug.

Symprove

Placebo OTHER

Matched placebo to Symprove probiotic

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic patients who are hospitalised with respiratory COVID-19
• Ability to give informed consent
• Aged 20-85

You may not qualify if:

• Inability to consent
• Pregnancy
• Severe pre-existing mental health disorders or addictions

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

Institute of Liver Studies

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Bu'Hussain Hayee, BSc, MBBS, FRCP, PhD

CONTACT

02032998848; b.hayee@nhs.net

Refah Z Ahmed, BA MSc

CONTACT

02032997150; refah.ahmed1@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 7, 2021
• Study Start: May 31, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)