NCT04741841

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

January 19, 2021

Last Update Submit

October 13, 2021

Conditions

Myalgic EncephalomyelitisChronic Fatigue Syndrome

Keywords

Myalgic EncephalomyelitisChronic Fatigue SyndromeME/CFSPost Viral FatiguePost Viral Fatigue SyndromeFatiguePost Exertional MalaisePEMIrritable Bowel SyndromeIBSLactobacillusProbioticGutMagnific

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Treatment high dose

ACTIVE COMPARATOR

High dose GutMagnific™

Dietary Supplement: GutMagnific™ H.

Treatment low dose

ACTIVE COMPARATOR

Low dose GutMagnific™

Dietary Supplement: GutMagnific™ L.

Interventions

GutMagnific™ H.DIETARY_SUPPLEMENT

Vegan Capsules with active product, GutMagnific™ high dose

Treatment high dose
GutMagnific™ L.DIETARY_SUPPLEMENT

Vegan Capsules with active product, GutMagnific™ low dose

Treatment low dose
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) at Stora Sköndals Neurological Rehabilitation Clinic
  • Gastrointestinal complications similar to IBS

You may not qualify if:

  • Consumption of any probiotics two weeks before enrolment
  • Consumption of other probiotic products during the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurological Rehabilitation Clinic in Stora Sköndal

Stockholm, Sweden

Location

MeSH Terms

Conditions

Fatigue Syndrome, ChronicFatigueIrritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsColonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Per Julin, MD/PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Pre-masked randomized vegan capsules with probiotic "GutMagnific" in 2 different doses, or corresponding placebo
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2021

First Posted

February 5, 2021

Study Start

March 30, 2020

Primary Completion

March 30, 2021

Study Completion

June 30, 2021

Last Updated

October 14, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)