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The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 4, 2025 (before its estimated February 24, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jan 2025 to Feb 24, 2026
    • Study completion date: Dec 2025 to Feb 24, 2026
    v3
  2. Primary completion date: Sep 2024 to Jan 2025
    • Study completion date: Dec 2024 to Dec 2025
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06211062
Lead Sponsor Nova Southeastern University
Conditions
(from sponsor)		 ME/CFS, IBS - Irritable Bowel Syndrome
Related terms Fatigue Syndrome, Chronic, Irritable Bowel Syndrome
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov