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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Myalgic Encephalomyelitis, Chronic Fatigue Syndrome

Intervention / Treatment
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* Dietary Supplement: GutMagnific™ H.
* Dietary Supplement: GutMagnific™ L.
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>The placebo product is identical to active product in taste and appearance but without probiotic | Dietary Supplement: Placebo<br>* Vegan capsules identical to active product in taste and appearance but without probiotic<br>|
| Active Comparator: Treatment high dose<br>High dose GutMagnific™ | Dietary Supplement: GutMagnific™ H.<br>* Vegan Capsules with active product, GutMagnific™ high dose<br>|
| Active Comparator: Treatment low dose<br>Low dose GutMagnific™ | Dietary Supplement: GutMagnific™ L.<br>* Vegan Capsules with active product, GutMagnific™ low dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At the baseline and weekly for 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 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. | 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. | At the baseline and after 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post Viral Fatigue, Post Viral Fatigue Syndrome, Fatigue, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, ME/CFS, Post Exertional Malaise, PEM, Irritable Bowel Syndrome, IBS, Lactobacillus, Probiotic, GutMagnific