Effect of Probiotics in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Primary Purpose
Myalgic Encephalomyelitis, Chronic Fatigue Syndrome
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
GutMagnific™ H.
GutMagnific™ L.
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Myalgic Encephalomyelitis focused on measuring Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, ME/CFS, Post Viral Fatigue, Post Viral Fatigue Syndrome, Fatigue, Post Exertional Malaise, PEM, Irritable Bowel Syndrome, IBS, Lactobacillus, Probiotic, GutMagnific
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
Sites / Locations
- Neurological Rehabilitation Clinic in Stora Sköndal
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
Treatment high dose
Treatment low dose
Arm Description
The placebo product is identical to active product in taste and appearance but without probiotic
High dose GutMagnific™
Low dose GutMagnific™
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Changes in the gastrointestinal symptoms based on Rome III criteria
Rome III questionnaire for IBS filled up by participants
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.
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.
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.
Full Information
NCT ID
NCT04741841
First Posted
January 19, 2021
Last Updated
October 13, 2021
Sponsor
ImmuneBiotech Medical Sweden AB
Collaborators
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT04741841
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 30, 2020 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmuneBiotech Medical Sweden AB
Collaborators
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myalgic Encephalomyelitis, Chronic Fatigue Syndrome
Keywords
Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, ME/CFS, Post Viral Fatigue, Post Viral Fatigue Syndrome, Fatigue, Post Exertional Malaise, PEM, Irritable Bowel Syndrome, IBS, Lactobacillus, Probiotic, GutMagnific
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Pre-masked randomized vegan capsules with probiotic "GutMagnific" in 2 different doses, or corresponding placebo
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo product is identical to active product in taste and appearance but without probiotic
Arm Title
Treatment high dose
Arm Type
Active Comparator
Arm Description
High dose GutMagnific™
Arm Title
Treatment low dose
Arm Type
Active Comparator
Arm Description
Low dose GutMagnific™
Intervention Type
Dietary Supplement
Intervention Name(s)
GutMagnific™ H.
Intervention Description
Vegan Capsules with active product, GutMagnific™ high dose
Intervention Type
Dietary Supplement
Intervention Name(s)
GutMagnific™ L.
Intervention Description
Vegan Capsules with active product, GutMagnific™ low dose
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Vegan capsules identical to active product in taste and appearance but without probiotic
Primary Outcome Measure Information:
Title
Changes in ME/CFS symptoms
Description
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
Secondary Outcome Measure Information:
Title
Changes in Irritable Bowel Syndrome (IBS) symptoms
Description
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
Title
Changes in the gastrointestinal symptoms based on Rome III criteria
Description
Rome III questionnaire for IBS filled up by participants
Time Frame
At the baseline and after 3 & 4 months
Title
Changes in health related quality of life (RAND 36-Item Health Survey)
Description
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
Title
Changes in Hospital Anxiety and Depression Scale (HADS)
Description
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
Title
Changes in gut microbiota composition
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Julin, MD/PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurological Rehabilitation Clinic in Stora Sköndal
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Probiotics in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
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