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NCT06211062 · ClinicalTrials.gov registry record · Phase 2
The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
A Phase 2 study of IBS - Irritable Bowel Syndrome and ME/CFS, sponsored by Nova Southeastern University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06211062: Recruiting Phase 2 study of IBS - Irritable Bowel Syndrome and ME/CFS, sponsored by Nova Southeastern University.
NCT06211062 is a Phase 2 study of IBS - Irritable Bowel Syndrome and ME/CFS that is actively recruiting participants, run by Nova Southeastern University. The registered enrollment target is 100 participants, above the 66-participant average among 6 other IBS - Irritable Bowel Syndrome trials with a reported enrollment target (52% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06211062, a Phase 2 study of IBS - Irritable Bowel Syndrome and ME/CFS, is actively recruiting participants, sponsored by Nova Southeastern University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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 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).
Primary Outcome
Safety will be assessed by documenting the frequency and severity of adverse events using a standardized form at each visit.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Floradapt Intensive GI
Study Locations (1)
Florida
- Institute for Neuroimmune Medicine - Fort Lauderdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-12-20 |
| Est. Completion | 2026-02-24 |
| Phase | Phase 2 |
What NCT06211062 shows while recruiting
NCT06211062 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 66-participant average among 6 other IBS - Irritable Bowel Syndrome trials with a reported enrollment target (52% higher).
The record links to 2 conditions, with IBS - Irritable Bowel Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06211062 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06211062 about?
NCT06211062 is a clinical study titled "The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome". 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 effecti...
What is the current status of trial NCT06211062?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2022-12-20. Estimated completion is 2026-02-24.
What conditions does trial NCT06211062 study?
This clinical trial studies the following conditions: IBS - Irritable Bowel Syndrome, ME/CFS.
What interventions are being tested in trial NCT06211062?
The interventions under investigation include: Placebo (OTHER), Floradapt Intensive GI (DRUG).
Who is sponsoring clinical trial NCT06211062?
This trial is sponsored by Nova Southeastern University, which has 71 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06211062 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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