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

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Brief Title

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

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

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.
    

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 Type

Interventional


Primary Outcome

Changes in ME/CFS symptoms

Secondary Outcome

 Changes in Irritable Bowel Syndrome (IBS) symptoms

Condition

Myalgic Encephalomyelitis

Intervention

GutMagnific™ H.

Study Arms / Comparison Groups

 Placebo
Description:  The placebo product is identical to active product in taste and appearance but without probiotic

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

90

Start Date

March 30, 2020

Completion Date

March 30, 2022

Primary Completion Date

March 30, 2021

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Per Julin, MD/PhD, +46840029262, [email protected]

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT04741841

Organization ID

GM_ME/CFS_2020SE


Responsible Party

Sponsor

Study Sponsor

ImmuneBiotech Medical Sweden AB

Collaborators

 Karolinska Institutet

Study Sponsor

Per Julin, MD/PhD, Principal Investigator, Karolinska Institutet


Verification Date

February 2021