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

Not Applicable

Completed

• Conditions: Myalgic Encephalomyelitis; Chronic Fatigue Syndrome
• Interventions: Dietary Supplement: GutMagnific™ H.; Dietary Supplement: Placebo; Dietary Supplement: GutMagnific™ L.

• Registration Number: NCT04741841
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2020-03-30
• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-05
• Primary Completion: 2021-03-30
• Study Completion: 2021-06-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment high dose	GutMagnific™ H.	High dose GutMagnific™
Placebo	Placebo	The placebo product is identical to active product in taste and appearance but without probiotic
Treatment low dose	GutMagnific™ L.	Low dose GutMagnific™

Primary Outcome Measures

Name	Time	Method
Changes in ME/CFS symptoms	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Hospital Anxiety and Depression Scale (HADS)	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	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.
Changes in Irritable Bowel Syndrome (IBS) symptoms	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	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)	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.

Trial Locations

Locations (1)

Neurological Rehabilitation Clinic in Stora Sköndal; 🇸🇪 Stockholm, Sweden