Long COVIDNCT05975034
Investigation of the Use of a Probiotic Supplement in People With Long COVID
A study testing Probiotic in people with Long COVID, run by Sheffield Hallam University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jun 2023to 11 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
-
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Sheffield Hallam University
Sheffield, S1 1WB
Caroline Dalton, PhD, 44-114-225-3695, c.f.dalton@shu.ac.uk
About this study
This study is a double-blinded randomised trial to assess the efficacy of a probiotic supplement in alleviating symptoms in people with Long COVID.
Read the 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.
- Conditions
- Long COVID
- Being tested
- Probiotic, Placebo
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Probiotic taken daily for 12 weeks.
PlaceboDietary supplement
Placebo taken daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Participants assigned to the probiotic group. Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Participants assigned to the placebo group. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue severity scale (FSS)
9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle
Measured: 12 weeks
FACIT fatigue scale
Measure that assesses self-reported fatigue and its impact upon daily activities and function
Measured: 12 weeks
EQ-5D-5L
Multi-attribute generic health status measure
Measured: 12 weeks
Ability to Participate in Social Roles and Activities - PROMIS Short Form 8a
Evaluation of ability to participate in social roles and activities
Measured: 12 weeks
Ecological Momentary Assessment (EMA) app
Symptom data collected using an app (sleep, fatigue, pain, breathlessness, light-headedness, cognitive difficulties)
Measured: 12 weeks
Secondary outcomes (8)
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
Measured: 12 weeks
Gastrointestinal Symptom Rating Scale
15 items in five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation
Measured: 12 weeks
MRC Dyspnoea scale
Assesses the degree of functional disability due to dyspnoea
Measured: 12 weeks
International. Physical Activity Questionnaire (short form)
Assesses moderate-to-vigorous physical activity and sedentary behaviour
Measured: 12 weeks
Accelerometery data
Longitudinal measurement of movement
Measured: 12 weeks
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Computer-based cognitive assessment system
Measured: 12 weeks
16S rRNA sequencing
Analysis of the composition and diversity of the gut microbiome
Measured: 12 weeks
Analysis of inflammatory markers
Measurement of cytokines (including IL-8, IL-6) by ELISA
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start12 Jun 2023
- Primary completion11 Dec 2023 (estimated)
- Study completion11 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded randomised trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Collaborators
- Symprove UK, Biomesight
- Responsible party
- Sponsor
- Investigators
- Caroline Dalton, PhD, Principal investigator, Sheffield Hallam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975034
- Sponsor's protocol ID
- ER45883322
- Status last verified
- Aug 2023
- First submitted
- 2 Aug 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Use of a Probiotic Supplement in People With Long COVID
- ClinicalTrials.gov ID
- NCT05975034
- Acronym / sponsor ID
- ER45883322
- Conditions
- Long COVID
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Collaborators
- Symprove UK, Biomesight
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 11 Dec 2023 (estimated)
- Study completion
- 11 Dec 2023 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded randomised trial
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticParticipants assigned to the probiotic group. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants assigned to the placebo group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticProbiotic taken daily for 12 weeks. | Dietary supplement | Probiotic |
| PlaceboPlacebo taken daily for 12 weeks. | Dietary supplement | Placebo |
Primary outcome
Fatigue severity scale (FSS)
Time frame: 12 weeks
9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle
FACIT fatigue scale
Time frame: 12 weeks
Measure that assesses self-reported fatigue and its impact upon daily activities and function
EQ-5D-5L
Time frame: 12 weeks
Multi-attribute generic health status measure
Ability to Participate in Social Roles and Activities - PROMIS Short Form 8a
Time frame: 12 weeks
Evaluation of ability to participate in social roles and activities
Ecological Momentary Assessment (EMA) app
Time frame: 12 weeks
Symptom data collected using an app (sleep, fatigue, pain, breathlessness, light-headedness, cognitive difficulties)
8 secondary outcomes
IBS-SSS
Time frame: 12 weeks
Gastrointestinal Symptom Rating Scale
Time frame: 12 weeks
MRC Dyspnoea scale
Time frame: 12 weeks
International. Physical Activity Questionnaire (short form)
Time frame: 12 weeks
Accelerometery data
Time frame: 12 weeks
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: 12 weeks
16S rRNA sequencing
Time frame: 12 weeks
Analysis of inflammatory markers
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Dalton, PhD principal investigator
Sheffield Hallam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Long COVID, run by Sheffield Hallam University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Dalton, PhD (44-114-225-3695, c.f.dalton@shu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue severity scale (FSS) (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.