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

Not Applicable

Recruiting

• Conditions: Long COVID
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Probiotic

• Registration Number: NCT05975034
• Lead Sponsor: Sheffield Hallam University

Brief Summary

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

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 Timeline

• Study Start: 2023-06-12
• Status Verified: 2023-08
• Study First Submitted: 2023-08-02
• Study First Submitted QC: 2023-08-02
• Last Update Submitted: 2023-08-02
• Study First Posted: 2023-08-03
• Last Update Posted: 2023-08-03
• Primary Completion: 2023-12-11
• Study Completion: 2023-12-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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).

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants assigned to the placebo group.
Probiotic	Probiotic	Participants assigned to the probiotic group.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sheffield Hallam University; 🇬🇧 Sheffield, United Kingdom