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

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

Sponsors

Lead Sponsor: ImmuneBiotech Medical Sweden AB

Collaborator: Karolinska Institutet

Source ImmuneBiotech Medical Sweden AB
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.

Overall Status Completed
Start Date 2020-03-30
Completion Date 2021-06-30
Primary Completion Date 2021-03-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes in ME/CFS symptoms At the baseline and weekly for 4 months
Secondary Outcome
Measure Time Frame
Changes in Irritable Bowel Syndrome (IBS) symptoms At the baseline and weekly for 4 months
Changes in the gastrointestinal symptoms based on Rome III criteria At the baseline and after 3 & 4 months
Changes in health related quality of life (RAND 36-Item Health Survey) At the baseline and monthly for 4 months
Changes in Hospital Anxiety and Depression Scale (HADS) At the baseline and after 3 & 4 months
Changes in gut microbiota composition At the baseline and after 3 months
Enrollment 74
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: GutMagnific™ H.

Description: Vegan Capsules with active product, GutMagnific™ high dose

Arm Group Label: Treatment high dose

Intervention Type: Dietary Supplement

Intervention Name: GutMagnific™ L.

Description: Vegan Capsules with active product, GutMagnific™ low dose

Arm Group Label: Treatment low dose

Intervention Type: Dietary Supplement

Intervention Name: Placebo

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

Arm Group Label: Placebo

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

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Per Julin, MD/PhD Principal Investigator Karolinska Institutet
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Neurological Rehabilitation Clinic in Stora Sköndal
Location Countries

Sweden

Verification Date

2021-10-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Placebo

Type: Placebo Comparator

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

Label: Treatment high dose

Type: Active Comparator

Description: High dose GutMagnific™

Label: Treatment low dose

Type: Active Comparator

Description: Low dose GutMagnific™

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Masking Description: Pre-masked randomized vegan capsules with probiotic "GutMagnific" in 2 different doses, or corresponding placebo

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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