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

• ClinicalTrials.gov Identifier: NCT04741841
• Recruitment Status: Completed
• First Posted: February 5, 2021
• Last Update Posted: October 14, 2021
• Sponsor: ImmuneBiotech Medical Sweden AB
• Collaborator: Karolinska Institutet
• Information provided by (Responsible Party): ImmuneBiotech Medical Sweden AB

Tracking Information

• First Submitted Date: January 19, 2021
• First Posted Date: February 5, 2021
• Last Update Posted Date: October 14, 2021
• Actual Study Start Date: March 30, 2020
• Actual Primary Completion Date: March 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 4, 2021)

Changes in ME/CFS symptoms [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 4, 2021)

• Changes in Irritable Bowel Syndrome (IBS) symptoms [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.
• Changes in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 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 [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

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

Primary Purpose: Treatment

Condition

• Myalgic Encephalomyelitis
• Chronic Fatigue Syndrome

Intervention

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

Study Arms

• Placebo Comparator: Placebo
  The placebo product is identical to active product in taste and appearance but without probiotic
  Intervention: Dietary Supplement: Placebo
• Active Comparator: Treatment high dose
  High dose GutMagnific™
  Intervention: Dietary Supplement: GutMagnific™ H.
• Active Comparator: Treatment low dose
  Low dose GutMagnific™
  Intervention: Dietary Supplement: GutMagnific™ L.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 13, 2021): 74
• Original Estimated Enrollment (submitted: February 4, 2021): 90
• Actual Study Completion Date: June 30, 2021
• Actual Primary Completion Date: March 30, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT04741841
• Other Study ID Numbers: GM_ME/CFS_2020SE
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: ImmuneBiotech Medical Sweden AB
• Original Responsible Party: Same as current
• Current Study Sponsor: ImmuneBiotech Medical Sweden AB
• Original Study Sponsor: Same as current
• Collaborators: Karolinska Institutet

Investigators

• Principal Investigator: Per Julin, MD/PhD; Karolinska Institutet

• PRS Account: ImmuneBiotech Medical Sweden AB
• Verification Date: October 2021