The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age45-70
SponsorNova Southeastern University
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 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).
Eligibility criteria
Qualifiers
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,
Patients of childbearing potential must practice effective contraception during the study and be willing to continue contraception for at least six months after the intervention,
Disqualifiers
Probiotics in the past eight weeks,
Antibiotics in the past eight weeks,
Pregnancy or lactating women,
Medical conditions including short bowel syndrome, celiac disease, biliary disease, pancreatitis, inflammatory bowel disease (Crohn's disease, ulcerative colitis), severe cardiovascular, neurological condition, or liver failure,
Trial design
Treatments tested in this trial
- Floradapt Intensive GI
- Placebo
Treatment groups
100 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov