Myalgic EncephalomyelitisNCT04741841
Effect of Probiotics in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
A study testing GutMagnific™ H. and GutMagnific™ L. in people with Myalgic Encephalomyelitis and Chronic Fatigue Syndrome, run by ImmuneBiotech Medical Sweden AB at 1 site in Sweden.
Trial summary
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a neurological disease. Currently there is no effective treatment for ME/CFS due to unclear etiology of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myalgic Encephalomyelitis, Chronic Fatigue Syndrome
- What is being tested?
- GutMagnific™ H. and GutMagnific™ L.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteSweden
- Study dates
- 30 Mar 2020to 30 Jun 2021
- 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
Who may be able to join
- Clinical diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) at Stora Sköndals Neurological Rehabilitation Clinic
- Gastrointestinal complications similar to IBS
Who cannot join
- Consumption of any probiotics two weeks before enrolment
- Consumption of other probiotic products during the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Probiotic Food Supplement "GutMagnific™" in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), Also Known as Post-viral Fatigue Syndrome, and Comorbid Gastrointestinal Complications
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a neurological disease. Currently there is no effective treatment for ME/CFS due to unclear etiology of the disease. The aim of this randomized double-blind placebo-control clinical trial is to study the efficacy of the probiotic food supplement "GutMagnific™" in ME/CFS and comorbid gastrointestinal complications. The outcome of the study will be assessed based on the data from different self-reporting questionnaires and intestinal microbial flora analysis.
Read the detailed description
Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) is a neurological disease with different symptoms such as fatigue. Symptoms get worse by physical or mental exertion which usually persists for more than 24 hours (post-exertional malaise, PEM). ME/CFS is often characterized by reduced functional capacity, worsening social relationships and reduced ability to cope with work or study.
The exact cause of the ME/CFS is presently unknown however a history of viral infection is common among ME/CFS patients. Prolonged post viral fatigue can develop into a chronic illness and ME/CFS. Current research strongly suggests involvement of gastrointestinal tract and gut microflora disturbances in the pathogenesis with strong evidence supporting the role of imbalance of gut microflora, damaged gut barrier functions and dysfunctional immune responses. There are some features shared with gastrointestinal conditions like irritable bowel syndrome (IBS). GutMagnific™ is an evidence-based probiotic food supplement, scientifically designed to be effective in correcting imbalances of the gut microflora, repairing a damaged gut barrier and reducing inflammation. The strain combination in GutMagnific™ has been carefully designed for its efficacy in IBS and therefore it can be reasonably expected to be also effective in ME/CFS.
- Being tested
- GutMagnific™ H., GutMagnific™ L., Placebo
- Keywords
- Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, ME/CFS, Post Viral Fatigue, Post Viral Fatigue Syndrome, Fatigue, Post Exertional Malaise, PEM, Irritable Bowel Syndrome, IBS, Lactobacillus, Probiotic, GutMagnific
- Medical subject headings
- Fatigue Syndrome, Chronic, Fatigue, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GutMagnific™ H.Dietary supplement
Vegan Capsules with active product, GutMagnific™ high dose
GutMagnific™ L.Dietary supplement
Vegan Capsules with active product, GutMagnific™ low dose
PlaceboDietary supplement
Vegan capsules identical to active product in taste and appearance but without probiotic
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo product is identical to active product in taste and appearance but without probiotic Receives: Dietary Supplement: Placebo |
| Treatment high dose | Active comparator | High dose GutMagnific™ Receives: Dietary Supplement: GutMagnific™ H. |
| Treatment low dose | Active comparator | Low dose GutMagnific™ Receives: Dietary Supplement: GutMagnific™ L. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ME/CFS symptoms
ME/CFS symptom rating scale filled up weekly by participants, graded 0-4 to evaluate degree of disease burden, according to the diagnostic Canadian Criteria. Higher score indicating worse outcome.
Measured: At the baseline and weekly for 4 months
Secondary outcomes (5)
Changes in Irritable Bowel Syndrome (IBS) symptoms
Questionnaire for IBS filled up by participants, graded 1-10 to evaluate degree of different bowel symptoms. Higher score indicating better condition.
Measured: At the baseline and weekly for 4 months
Changes in the gastrointestinal symptoms based on Rome III criteria
Rome III questionnaire for IBS filled up by participants
Measured: At the baseline and after 3 & 4 months
Changes in health related quality of life (RAND 36-Item Health Survey)
RAND-36 questionnaire for health-related quality of life filled up by participants. The questionnaire evaluating eight health concepts: physical functioning, role limitations caused by physical health problem, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Possible score is 0 (lowest) to 100 (highest) for each item.
Measured: At the baseline and monthly for 4 months
Changes in Hospital Anxiety and Depression Scale (HADS)
HADS questionnaire for anxiety and depression filled up by participants.The questionnaire comprises questions for anxiety and depression. Each item on the questionnaire is scored from 0-3 and means that a person can score between 0 and 21 for either anxiety or depression. Higher score representing worse outcome.
Measured: At the baseline and after 3 & 4 months
Changes in gut microbiota composition
Fecal samples will be analysed using sequencing-based methods to monitor possible changes related to probiotic treatment. Samples taken prior to and after probiotic treatment in the same participant will be compared.
Measured: At the baseline and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start30 Mar 2020
- Primary completion30 Mar 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myalgic EncephalomyelitisStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmuneBiotech Medical Sweden AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Per Julin, MD/PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741841
- Sponsor's protocol ID
- GM_ME/CFS_2020SE
- Status last verified
- Oct 2021
- First submitted
- 19 Jan 2021
- Last updated
- 14 Oct 2021
- Results posted
- 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 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Food Supplement "GutMagnific™" in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), Also Known as Post-viral Fatigue Syndrome, and Comorbid Gastrointestinal Complications
- ClinicalTrials.gov ID
- NCT04741841
- Acronym / sponsor ID
- GM_ME/CFS_2020SE
- Keywords
- Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, ME/CFS, Post Viral Fatigue, Post Viral Fatigue Syndrome, Fatigue, Post Exertional Malaise, PEM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- ImmuneBiotech Medical Sweden ABIndustry (pharma, biotech, devices)
- Collaborators
- Karolinska Institutet
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 5 Feb 2021 (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.
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a neurological disease. Currently there is no effective treatment for ME/CFS due to unclear etiology of the disease. The aim of this randomized double-blind placebo-control clinical trial is to study the efficacy of the probiotic food supplement "GutMagnific™" in ME/CFS and comorbid gastrointestinal complications. The outcome of the study will be assessed based on the data from different self-reporting questionnaires and intestinal microbial flora analysis.
Detailed description
Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) is a neurological disease with different symptoms such as fatigue. Symptoms get worse by physical or mental exertion which usually persists for more than 24 hours (post-exertional malaise, PEM). ME/CFS is often characterized by reduced functional capacity, worsening social relationships and reduced ability to cope with work or study.
The exact cause of the ME/CFS is presently unknown however a history of viral infection is common among ME/CFS patients. Prolonged post viral fatigue can develop into a chronic illness and ME/CFS. Current research strongly suggests involvement of gastrointestinal tract and gut microflora disturbances in the pathogenesis with strong evidence supporting the role of imbalance of gut microflora, damaged gut barrier functions and dysfunctional immune responses. There are some features shared with gastrointestinal conditions like irritable bowel syndrome (IBS). GutMagnific™ is an evidence-based probiotic food supplement, scientifically designed to be effective in correcting imbalances of the gut microflora, repairing a damaged gut barrier and reducing inflammation. The strain combination in GutMagnific™ has been carefully designed for its efficacy in IBS and therefore it can be reasonably expected to be also effective in ME/CFS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo product is identical to active product in taste and appearance but without probiotic |
| Treatment high dose | Active comparator | Dietary Supplement: GutMagnific™ H.High dose GutMagnific™ |
| Treatment low dose | Active comparator | Dietary Supplement: GutMagnific™ L.Low dose GutMagnific™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) at Stora Sköndals Neurological Rehabilitation Clinic
- Gastrointestinal complications similar to IBS
Key exclusion criteria (2 listed)
- Consumption of any probiotics two weeks before enrolment
- Consumption of other probiotic products during the trial
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 |
|---|---|---|
| GutMagnific™ H.Vegan Capsules with active product, GutMagnific™ high dose | Dietary supplement | Treatment high dose |
| GutMagnific™ L.Vegan Capsules with active product, GutMagnific™ low dose | Dietary supplement | Treatment low dose |
| PlaceboVegan capsules identical to active product in taste and appearance but without probiotic | Dietary supplement | Placebo |
Primary outcome
Changes in ME/CFS symptoms
Time frame: At the baseline and weekly for 4 months
ME/CFS symptom rating scale filled up weekly by participants, graded 0-4 to evaluate degree of disease burden, according to the diagnostic Canadian Criteria. Higher score indicating worse outcome.
5 secondary outcomes
Changes in Irritable Bowel Syndrome (IBS) symptoms
Time frame: At the baseline and weekly for 4 months
Changes in the gastrointestinal symptoms based on Rome III criteria
Time frame: At the baseline and after 3 & 4 months
Changes in health related quality of life (RAND 36-Item Health Survey)
Time frame: At the baseline and monthly for 4 months
Changes in Hospital Anxiety and Depression Scale (HADS)
Time frame: At the baseline and after 3 & 4 months
Changes in gut microbiota composition
Time frame: At the baseline and after 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Myalgic Encephalomyelitis
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Enrolling by invitation
Fareon Open Label Device Clinical Trial
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Recruiting
Photobiomodulation in Chronic Fatigue Syndrome
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Low-Dose Naltrexone For ME/CFS: Dose-Finding
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The Precision Mito- Mito Map COMPASS Study
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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.
Per Julin, MD/PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GutMagnific™ H. and GutMagnific™ L. in people with Myalgic Encephalomyelitis and Chronic Fatigue Syndrome, run by ImmuneBiotech Medical Sweden AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. 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: finished, as of the sponsor's last update on 14 Oct 2021. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in ME/CFS symptoms (time frame: At the baseline and weekly for 4 months). 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 14 Oct 2021.