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

NCT05975034 | Unknown

• 1 other identifier: ER45883322
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Long COVID

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• IBS-SSS

  12 weeks

• Gastrointestinal Symptom Rating Scale

  12 weeks

• MRC Dyspnoea scale

  12 weeks

• International. Physical Activity Questionnaire (short form)

  12 weeks

• Accelerometery data

  12 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

Participants assigned to the probiotic group.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Participants assigned to the placebo group.

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Probiotic taken daily for 12 weeks.

Probiotic

Placebo DIETARY_SUPPLEMENT

Placebo taken daily for 12 weeks.

Placebo

Eligibility Criteria

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

Sponsors & Collaborators

• Sheffield Hallam University: lead
• Symprove UK: collaborator
• Biomesight: collaborator

Study Sites (1)

Sheffield Hallam University

Sheffield, S1 1WB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Probiotics

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Caroline Dalton, PhD

  Sheffield Hallam University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Dalton, PhD

CONTACT

44-114-225-3695; c.f.dalton@shu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Computerised randomisation by a researcher in a separate department, probiotic/placebo packaged in identical bottles (label indicates group A or B). Probiotic/placebo delivered directly from supplier to participants (without involvement of the investigators).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded randomised trial

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 3, 2023
• Study Start: June 12, 2023
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)