Using probiotics to treat Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
PHASE2 · Nova Southeastern University · NCT06211062
This study is testing if a new probiotic can help people aged 45 to 70 with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome and possibly irritable bowel syndrome feel better.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 45 Years to 70 Years |
| Sex | All |
| Sponsor | Nova Southeastern University (other) |
| Locations | 1 site (Fort Lauderdale, Florida) |
| Trial ID | NCT06211062 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the effectiveness of the i3.1 probiotic in participants aged 45 to 70 who meet the criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and may also have irritable bowel syndrome (IBS). The study is a randomized, placebo-controlled trial involving 100 participants, with half having co-morbid IBS. Participants will receive either the i3.1 probiotic or a placebo and will be assessed at baseline, eight weeks, and twelve weeks post-treatment to measure gastrointestinal inflammation and IBS severity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45 to 70 who meet the ME/CFS criteria and may have IBS.
Not a fit: Patients with recent use of probiotics or antibiotics, or those with certain gastrointestinal or severe medical conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for managing symptoms of ME/CFS and IBS.
How similar studies have performed: While the use of probiotics in gastrointestinal conditions has been explored, this specific application in ME/CFS is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Fort Lauderdale, Florida
- Institute for Neuroimmune Medicine — Fort Lauderdale, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Nancy Klimas, MD — Nova Southeastern University, Institute for Neuroimmune Medicine
- Study coordinator: Nancy Klimas, MD
- Email: nklimas@nova.edu
- Phone: 9542622855
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ME/CFS, IBS - Irritable Bowel Syndrome