The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
- NCT ID
- NCT06211062
- Registry status
- Recruiting
- Study type
- Not specified in the registry data
- Phase
- Phase 2
- Sponsor
- Nova Southeastern University
Overview
ClinicalTrials.gov lists this study as Recruiting.
Enrollment: 100 participants (Estimated).
What is being studied
No interventions are listed in the registry data.
Who may be eligible
- Ages
- Not specified in the registry data
- Sex
- Not specified in the registry data
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following 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.
Study locations
1 study location is listed.
Site recruitment status is not specified in the registry data for these locations.
Countries: United States
- Florida, United States: 1
Sample of listed locations
- Institute for Neuroimmune Medicine — Fort Lauderdale, Florida, 33314-7796, United States — Site recruitment status not specified in the registry data
Study details
- Start date
- December 20, 2022
- Primary completion date
- February 24, 2026
- First posted
- January 18, 2024
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT06211062
- Registry last updated
- March 4, 2025
- QualifiedStudies registry data refreshed
- September 21, 2026
View NCT06211062 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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