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

NCT04741841 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2021-10-14

No results posted yet for this study

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.

Conditions

  • Myalgic Encephalomyelitis
  • Chronic Fatigue Syndrome

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Per Julin, MD/PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-30
Primary Completion
2021-03-30
Completion
2021-06-30

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04741841 on ClinicalTrials.gov