Effect of Probiotics in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
|ClinicalTrials.gov Identifier: NCT04741841
Recruitment Status : Completed
First Posted : February 5, 2021
Last Update Posted : October 14, 2021
|Condition or disease
|Myalgic Encephalomyelitis Chronic Fatigue Syndrome
|Dietary Supplement: GutMagnific™ H. Dietary Supplement: GutMagnific™ L. Dietary Supplement: Placebo
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 Type :
|Interventional (Clinical Trial)
|Actual Enrollment :
|Triple (Participant, Care Provider, Investigator)
|Pre-masked randomized vegan capsules with probiotic "GutMagnific" in 2 different doses, or corresponding placebo
|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
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
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
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
|Neurological Rehabilitation Clinic in Stora Sköndal
|Per Julin, MD/PhD