Clinical trial NCT04741841: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: ImmuneBiotech Medical Sweden AB
Sponsor class: INDUSTRY
Collaborators: name: Karolinska Institutet
First posted: 2021-02-05
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in ME/CFS symptoms
timeFrame: At the baseline and weekly for 4 months
Secondary outcomes:
measure: Changes in Irritable Bowel Syndrome (IBS) symptoms
timeFrame: At the baseline and weekly for 4 months
measure: Changes in the gastrointestinal symptoms based on Rome III criteria
timeFrame: At the baseline and after 3 & 4 months
measure: Changes in health related quality of life (RAND 36-Item Health Survey)
timeFrame: At the baseline and monthly for 4 months
measure: Changes in Hospital Anxiety and Depression Scale (HADS)
timeFrame: At the baseline and after 3 & 4 months
measure: Changes in gut microbiota composition
timeFrame: At the baseline and after 3 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Neurological Rehabilitation Clinic in Stora Sköndal
Study officials:
affiliation: Karolinska Institutet
name: Per Julin, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: