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

Long COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05975034
• Other study ID #: ER45883322
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2023
• Est. completion date: December 11, 2023

Study information

• Verified date: August 2023
• Source: Sheffield Hallam University
• Contact: Caroline Dalton, PhD
• Phone: 44-114-225-3695
• Email: c.f.dalton[@]shu.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 11, 2023
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• Long COVID

Intervention

Dietary Supplement:
• Probiotic
Probiotic taken daily for 12 weeks.
• Placebo
Placebo taken daily for 12 weeks.

Locations

Country	Name	City	State
United Kingdom	Sheffield Hallam University	Sheffield

Sponsors (3)

Lead Sponsor	Collaborator
Sheffield Hallam University	Biomesight, Symprove UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	FACIT fatigue scale	Measure that assesses self-reported fatigue and its impact upon daily activities and function	12 weeks
Primary	EQ-5D-5L	Multi-attribute generic health status measure	12 weeks
Primary	Ability to Participate in Social Roles and Activities - PROMIS Short Form 8a	Evaluation of ability to participate in social roles and activities	12 weeks
Primary	Ecological Momentary Assessment (EMA) app	Symptom data collected using an app (sleep, fatigue, pain, breathlessness, light-headedness, cognitive difficulties)	12 weeks
Secondary	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
Secondary	Gastrointestinal Symptom Rating Scale	15 items in five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation	12 weeks
Secondary	MRC Dyspnoea scale	Assesses the degree of functional disability due to dyspnoea	12 weeks
Secondary	International. Physical Activity Questionnaire (short form)	Assesses moderate-to-vigorous physical activity and sedentary behaviour	12 weeks
Secondary	Accelerometery data	Longitudinal measurement of movement	12 weeks
Secondary	Cambridge Neuropsychological Test Automated Battery (CANTAB)	Computer-based cognitive assessment system	12 weeks
Secondary	16S rRNA sequencing	Analysis of the composition and diversity of the gut microbiome	12 weeks
Secondary	Analysis of inflammatory markers	Measurement of cytokines (including IL-8, IL-6) by ELISA	12 weeks