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

Chronic Fatigue Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04741841
• Other study ID #: GM_ME/CFS_2020SE
• Status: Completed
• Phase: N/A
• Start date: March 30, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2021
• Source: ImmuneBiotech Medical Sweden AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) at Stora Sko¨ndals 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

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Encephalomyelitis
• Fatigue
• Fatigue Syndrome, Chronic
• Myalgia
• Myalgic Encephalomyelitis
• Syndrome

Intervention

Dietary Supplement:
• GutMagnific™ H.
Vegan Capsules with active product, GutMagnific™ high dose
• GutMagnific™ L.
Vegan Capsules with active product, GutMagnific™ low dose
• Placebo
Vegan capsules identical to active product in taste and appearance but without probiotic

Locations

Country	Name	City	State
Sweden	Neurological Rehabilitation Clinic in Stora Sköndal	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
ImmuneBiotech Medical Sweden AB	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the baseline and weekly for 4 months
Secondary	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.	At the baseline and weekly for 4 months
Secondary	Changes in the gastrointestinal symptoms based on Rome III criteria	Rome III questionnaire for IBS filled up by participants	At the baseline and after 3 & 4 months
Secondary	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.	At the baseline and monthly for 4 months
Secondary	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.	At the baseline and after 3 & 4 months
Secondary	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.	At the baseline and after 3 months