The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Recruiting Phase 2 Interventional Study
ME/CFS IBS - Irritable Bowel Syndrome
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
45 – 70
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Nova Southeastern University · Other
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About This Trial
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: * how effective is the usage of the i3.1 probiotic to reduce gastrointestinal (GI) inflammation and normalize the…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: eligible if all of the following apply: * Meets IOM ME/CFS case definition criteria, * Co-morbid IBS: meets RomeIV criteria for alternating or diarrhea-predominant IBS as reported during screening (technically diagnosed by a physician), * Able to provide consent to study, * Pati…
Contacts

Nancy Klimas, MD

9542622855

nklimas@nova.edu

CONTACT

Devra Cohen, MPH

9542621487

dcohen1@nova.edu

CONTACT