An interventional study of GutMagnific™ H. and GutMagnific™ L. in Myalgic Encephalomyelitis and Chronic Fatigue Syndrome, sponsored by ImmuneBiotech Medical Sweden AB. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-14.
Sponsored by ImmuneBiotech Medical Sweden AB · Not applicable, Interventional, and Treatment
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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.
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.
264 studies on the registry are indexed under Fatigue Syndrome, Chronic; 62 are open to participants now.
This study's enrollment of 74 is above the median of 60 across 178 interventional studies indexed under Fatigue Syndrome, Chronic.
Browse Fatigue Syndrome, Chronic studies →This is the only study on the registry with ImmuneBiotech Medical Sweden AB as lead sponsor.
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Exclusion Criteria:
The placebo product is identical to active product in taste and appearance but without probiotic
Dietary Supplement: Placebo
High dose GutMagnific™
Dietary Supplement: GutMagnific™ H.
Low dose GutMagnific™
Dietary Supplement: GutMagnific™ L.
Vegan Capsules with active product, GutMagnific™ high dose
Vegan Capsules with active product, GutMagnific™ low dose
Vegan capsules identical to active product in taste and appearance but without probiotic
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.
Time frame: At the baseline and weekly for 4 months
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At the baseline and after 3 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2020 to primary completion in Mar 2021, 12 months.
Of 78 interventional studies with no phase under Fatigue Syndrome, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 12 months is below that.
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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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