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Effect of Probiotics in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

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ClinicalTrials.gov Identifier: NCT04741841
Recruitment Status : Completed
First Posted : February 5, 2021
Last Update Posted : October 14, 2021
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
ImmuneBiotech Medical Sweden AB

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Myalgic Encephalomyelitis Chronic Fatigue Syndrome Dietary Supplement: GutMagnific™ H. Dietary Supplement: GutMagnific™ L. Dietary Supplement: Placebo Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Pre-masked randomized vegan capsules with probiotic "GutMagnific" in 2 different doses, or corresponding placebo
Primary Purpose: Treatment
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
Actual Study Start Date : March 30, 2020
Actual Primary Completion Date : March 30, 2021
Actual Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
The placebo product is identical to active product in taste and appearance but without probiotic
 Dietary Supplement: Placebo
Vegan capsules identical to active product in taste and appearance but without probiotic
Active Comparator: Treatment high dose
High dose GutMagnific™
 Dietary Supplement: GutMagnific™ H.
Vegan Capsules with active product, GutMagnific™ high dose
Active Comparator: Treatment low dose
Low dose GutMagnific™
 Dietary Supplement: GutMagnific™ L.
Vegan Capsules with active product, GutMagnific™ low dose


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Changes in Irritable Bowel Syndrome (IBS) symptoms [ Time Frame: At the baseline and weekly for 4 months ]
    Questionnaire for IBS filled up by participants, graded 1-10 to evaluate degree of different bowel symptoms. Higher score indicating better condition.

  2. Changes in the gastrointestinal symptoms based on Rome III criteria [ Time Frame: At the baseline and after 3 & 4 months ]
    Rome III questionnaire for IBS filled up by participants

  3. Changes in health related quality of life (RAND 36-Item Health Survey) [ Time Frame: At the baseline and monthly for 4 months ]
    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.

  4. Changes in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: At the baseline and after 3 & 4 months ]
    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.

  5. Changes in gut microbiota composition [ Time Frame: At the baseline and after 3 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) at Stora Sköndals Neurological Rehabilitation Clinic
  • Gastrointestinal complications similar to IBS

Exclusion Criteria:

  • Consumption of any probiotics two weeks before enrolment
  • Consumption of other probiotic products during the trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04741841


Locations
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Sweden
Neurological Rehabilitation Clinic in Stora Sköndal
Stockholm, Sweden
Sponsors and Collaborators
ImmuneBiotech Medical Sweden AB
Karolinska Institutet
Investigators
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Principal Investigator: Per Julin, MD/PhD Karolinska Institutet
More Information
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Responsible Party: ImmuneBiotech Medical Sweden AB
ClinicalTrials.gov Identifier: NCT04741841    
Other Study ID Numbers: GM_ME/CFS_2020SE
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ImmuneBiotech Medical Sweden AB:
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
Additional relevant MeSH terms:
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Encephalomyelitis
Fatigue Syndrome, Chronic
Myalgia
Syndrome
Fatigue
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
 Neuroinflammatory Diseases
Nervous System Diseases
Neuromuscular Diseases
Central Nervous System Infections
Infections
Central Nervous System Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations