Status:
RECRUITING
The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Lead Sponsor:
Nova Southeastern University
Conditions:
ME/CFS
IBS - Irritable Bowel Syndrome
Eligibility:
All Genders
45-70 years
Phase:
PHASE2
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 dia...
Detailed Description
This single-site comparison study will be performed on 100 participants, 45 to 70 years of age, who meet the Institute of Medicine (Canadian Consensus Criteria) case definition for ME/CFS and who may ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 24 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06211062
Start Date
December 20 2022
End Date
February 24 2026
Last Update
March 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute for Neuroimmune Medicine
Fort Lauderdale, Florida, United States, 33314-7796