Investigation of the Use of a Probiotic Supplement in People With Long COVID

This study is a double-blinded randomised trial to assess the efficacy of a probiotic supplement in alleviating symptoms in people with Long COVID.

Study Overview

• Status: Recruiting
• Conditions: Long COVID
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

Detailed Description

240 participants with Long COVID will be randomly assigned to either a probiotic or placebo group in a 1:1 ratio for twelve weeks. Participants will track symptoms using an app for three weeks before the study, and for the last three weeks of the treatment. Participants will answer online questionnaires about their symptoms at 0, 4, 8, and 12 weeks. A subgroup of 60 participants will attend the laboratory for blood tests, cognitive function tests and gut microbiome analysis at 0 and 12 weeks. This group will also wear activity trackers for two weeks before the study, and for the final two weeks of the study.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline Dalton, PhD; Phone Number: 44-114-225-3695; Email: c.f.dalton@shu.ac.uk

Study Locations

• United Kingdom
  • Sheffield, United Kingdom, S1 1WB
    • Recruiting
    • Sheffield Hallam University
    • Contact: Caroline Dalton, PhD; Phone Number: 44-114-225-3695; Email: c.f.dalton@shu.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Long COVID defined as National Institute for Health and Care Excellence (NICE) criteria for Long COVID (Persistent symptoms at least 12 weeks after a confirmed or suspected Covid-19 infection).

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Exclusion Criteria: Significant co-morbidities - no pre-existing diagnosis of hypertension, diabetes, cerebrovascular, cardiovascular or peripheral vascular disease, coagulopathy or haematological disorder or current or recent cancer.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic; Participants assigned to the probiotic group.	Dietary supplement: Probiotic; Probiotic taken daily for 12 weeks.
Placebo Comparator: Placebo; Participants assigned to the placebo group.	Dietary supplement: Placebo; Placebo taken daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue severity scale (FSS)	9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle	12 weeks
FACIT fatigue scale	Measure that assesses self-reported fatigue and its impact upon daily activities and function	12 weeks
EQ-5D-5L	Multi-attribute generic health status measure	12 weeks
Ability to Participate in Social Roles and Activities - PROMIS Short Form 8a	Evaluation of ability to participate in social roles and activities	12 weeks
Ecological Momentary Assessment (EMA) app	Symptom data collected using an app (sleep, fatigue, pain, breathlessness, light-headedness, cognitive difficulties)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBS-SSS	Composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life	12 weeks
Gastrointestinal Symptom Rating Scale	15 items in five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation	12 weeks
MRC Dyspnoea scale	Assesses the degree of functional disability due to dyspnoea	12 weeks
International. Physical Activity Questionnaire (short form)	Assesses moderate-to-vigorous physical activity and sedentary behaviour	12 weeks
Accelerometery data	Longitudinal measurement of movement	12 weeks
Cambridge Neuropsychological Test Automated Battery (CANTAB)	Computer-based cognitive assessment system	12 weeks
16S rRNA sequencing	Analysis of the composition and diversity of the gut microbiome	12 weeks
Analysis of inflammatory markers	Measurement of cytokines (including IL-8, IL-6) by ELISA	12 weeks

Collaborators and Investigators

• Sponsor: Sheffield Hallam University
• Collaborators: Symprove UK; Biomesight
• Investigators: Principal Investigator: Caroline Dalton, PhD, Sheffield Hallam University

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Estimated): December 11, 2023
• Study Completion (Estimated): December 11, 2023

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: ER45883322

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