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Completed

NCT Number: NCT04741841

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

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.

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Key information

Conditions

Myalgic Encephalomyelitis Chronic Disease Chronic Fatigue Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Disease Attributes Encephalomyelitis Fatigue Fatigue Syndrome, Chronic Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurological Rehabilitation Clinic in Stora Sköndal

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GutMagnific™ H.

Dietary Supplement

Vegan Capsules with active product, GutMagnific™ high dose

GutMagnific™ L.

Dietary Supplement

Vegan Capsules with active product, GutMagnific™ low dose

Placebo

Dietary Supplement

Vegan capsules identical to active product in taste and appearance but without probiotic

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

ImmuneBiotech Medical Sweden AB

Industry

Collaborators

  • Karolinska Institutet

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2021
Registry last updated
Oct 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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