NCT06211062 The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
| NCT ID | NCT06211062 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Nova Southeastern University |
| Condition | ME/CFS |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-12-20 |
| Primary Completion | 2026-02-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2022-12-20 with a primary completion date of 2026-02-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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, * 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, * agrees to participate in online surveys and follow-up visits. Exclusion Criteria: ineligible if any of the following apply: * 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, * Gastrointestinal surgery within six months of study entry, * History of psychiatric disorder, alcohol or illicit drug abuse.
Contact & Investigator
Nancy Klimas, MD
PRINCIPAL INVESTIGATOR
Nova Southeastern University, Institute for Neuroimmune Medicine
Frequently Asked Questions
Who can join the NCT06211062 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 70 Years, studying ME/CFS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06211062 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06211062 currently recruiting?
Yes, NCT06211062 is actively recruiting participants. Contact the research team at nklimas@nova.edu for enrollment information.
Where is the NCT06211062 trial being conducted?
This trial is being conducted at Fort Lauderdale, United States.
Who is sponsoring the NCT06211062 clinical trial?
NCT06211062 is sponsored by Nova Southeastern University. The principal investigator is Nancy Klimas, MD at Nova Southeastern University, Institute for Neuroimmune Medicine. The trial plans to enroll 100 participants.