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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
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
ImmuneBiotech Medical Sweden AB

Tracking Information
First Submitted Date  ICMJE January 19, 2021
First Posted Date  ICMJE February 5, 2021
Last Update Posted Date October 14, 2021
Actual Study Start Date  ICMJE March 30, 2020
Actual Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2021)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Probiotics in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Pre-masked randomized vegan capsules with probiotic "GutMagnific" in 2 different doses, or corresponding placebo
Primary Purpose: Treatment
Condition  ICMJE
  • Myalgic Encephalomyelitis
  • Chronic Fatigue Syndrome
Intervention  ICMJE
  • Dietary Supplement: GutMagnific™ H.
    Vegan Capsules with active product, GutMagnific™ high dose
  • Dietary Supplement: GutMagnific™ L.
    Vegan Capsules with active product, GutMagnific™ low dose
  • Dietary Supplement: Placebo
    Vegan capsules identical to active product in taste and appearance but without probiotic
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    The placebo product is identical to active product in taste and appearance but without probiotic
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: Treatment high dose
    High dose GutMagnific™
    Intervention: Dietary Supplement: GutMagnific™ H.
  • Active Comparator: Treatment low dose
    Low dose GutMagnific™
    Intervention: Dietary Supplement: GutMagnific™ L.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2021)
74
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2021)
90
Actual Study Completion Date  ICMJE June 30, 2021
Actual Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04741841
Other Study ID Numbers  ICMJE GM_ME/CFS_2020SE
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party ImmuneBiotech Medical Sweden AB
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ImmuneBiotech Medical Sweden AB
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Karolinska Institutet
Investigators  ICMJE
Principal Investigator: Per Julin, MD/PhD Karolinska Institutet
PRS Account ImmuneBiotech Medical Sweden AB
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP