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This clinical study aims to evaluate the use of i3.1 probiotic in participants who meet the Institute of Medicine (Canadian Consensus Criteria) case definition for ME/CFS and who may or may not be diagnosed with irritable bowel syndrome (IBS). The main questions it aims to answer are:
Full description
This single-site comparison study will be performed on 100 participants, 45 to 70 years of age, who meet the Institute of Medicine (Canadian Consensus Criteria) case definition for ME/CFS and who may or may not be diagnosed with the irritable bowel syndrome (IBS), according to the Rome IV criteria. In this study, we will evaluate using the i3.1 probiotic compared to placebo. This is a randomized, placebo-controlled trial with four study arms that will include 25 participants per arm: Individuals with ME/CFS with and without IBS, who will take either the active medication i3.1 or placebo.
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Inclusion and exclusion criteria
Inclusion Criteria: eligible if all of the following apply:
Exclusion Criteria: ineligible if any of the following apply:
Primary purpose
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Interventional model
Masking
100 participants in 4 patient groups, including a placebo group
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Central trial contact
Devra Cohen, MPH; Nancy Klimas, MD
Data sourced from clinicaltrials.gov
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