NCT06211062 · ClinicalTrials.gov record · last posted 2025-03-04
The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
StatusRecruiting
PhasePhase 2
Started2022-12-20
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.
from the ClinicalTrials.gov record
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).
Amendment record
2 amendments on the ClinicalTrials.gov record
This ClinicalTrials.gov record has been amended 2 times since 2024-01-17; most recent amendment 2025-03-03. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history.
See every version on ClinicalTrials.gov ↗
| NCT Number |
NCT06211062 |
| Lead Sponsor |
Nova Southeastern University
|
| Conditions |
ME/CFS, IBS - Irritable Bowel Syndrome |
| Enrollment |
100 participants |
| Start Date |
2022-12-20 |
| Primary Completion |
2026-02-24 (estimated) |
| Study Completion |
2026-02-24 (estimated) |
| Updated on ClinicalTrials.gov |
2025-03-04 |