Actively Recruiting
The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Led by Nova Southeastern University · Updated on 2025-03-04
100
Participants Needed
1
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meets Institute of Medicine (IOM) ME/CFS case definition criteria
- If co-morbid IBS, meets Rome IV criteria for alternating or diarrhea-predominant IBS as reported during screening
- Able to provide consent to participate in the study
- Patients of childbearing potential must use effective contraception during the study and for at least six months after intervention
- Willing to participate in online surveys and follow-up visits
You will not qualify if you...
- Use of probiotics in the past eight weeks
- Use of antibiotics in the past eight weeks
- Pregnancy or breastfeeding
- Medical conditions such as short bowel syndrome, celiac disease, biliary disease, pancreatitis, inflammatory bowel disease (Crohn's disease, ulcerative colitis), severe cardiovascular or neurological conditions, or liver failure
- Gastrointestinal surgery within six months before study entry
- History of psychiatric disorder, alcohol abuse, or illicit drug abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute for Neuroimmune Medicine
Fort Lauderdale, Florida, United States, 33314-7796
Actively Recruiting
Research Team
N
Nancy Klimas, MD
CONTACT
D
Devra Cohen, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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