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The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Sponsor: Nova Southeastern University
Summary
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 GI and systemic/brain interface? * how well is it working on IBS severity? The study sample is 100 male and female participants aged 45 to 70 years with ME/CFS (per the Canadian Consensus Criteria); one-half of the participants will have co-morbid IBS (per Rome IV criteria). Participants will receive an i3.1 or a placebo and be assessed at baseline, at eight weeks, and at 12 weeks (four weeks post-treatment completion).
Key Details
Gender
All
Age Range
45 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2022-12-20
Completion Date
2026-02-24
Last Updated
2025-03-04
Healthy Volunteers
No
Conditions
Interventions
Floradapt Intensive GI
one capsule daily for the eight week intervention
Placebo
one capsule daily for the eight week intervention
Locations (1)
Institute for Neuroimmune Medicine
Fort Lauderdale, Florida, United States