NCT06211062RecruitingPhase 2
The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Source: ClinicalTrials.gov · Last updated 4 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 1 Aug 2023
- Start date
- 20 Dec 2022
- Primary completion date
- 24 Feb 2026
- Lead sponsor
- Nova Southeastern University
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06211062
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 20 Dec 2022 to the primary completion date, 24 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Gastrointestinal surgery within six months of study entry,
Other illness
- 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,
- History of psychiatric disorder, alcohol or illicit drug abuse.
Other
- Probiotics in the past eight weeks,
- Antibiotics in the past eight weeks,
- Pregnancy or lactating women,
Who the study is looking for
- 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.
Age in the registry: 45 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute for Neuroimmune Medicine Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.