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

Part of paid clinical trials in Fort Lauderdale, Florida.

Sponsor
Nova Southeastern University
Study ID
NCT06211062
Phase
PHASE2
Status
Recruiting
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Conditions

  • IBS - Irritable Bowel Syndrome
  • ME/CFS

Eligibility Criteria

Sex
ALL
Age
45 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Floradapt Intensive GI — DRUG
    one capsule daily for the eight week intervention
  • Placebo — OTHER
    one capsule daily for the eight week intervention

Study Details

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).

Key Dates

Start date
Dec 20, 2022
Status verified
Mar 2025
Primary completion
Feb 24, 2026
Completion
Feb 24, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Individuals with ME/CFS with IBS on active medication
    Individuals with ME/CFS with IBS take Floradapt Intensive GI (another name i3.1), one high dose capsule (\>3x10 to the ninth power) once daily for eight weeks.
  • Placebo Comparator: Individuals with ME/CFS with IBS on placebo
    Individuals with ME/CFS with IBS take a placebo, one capsule once daily for eight weeks.
  • Active Comparator: Individuals with ME/CFS without IBS on active medication
    Individuals with ME/CFS without IBS take Floradapt Intensive GI (another name i3.1), one high dose capsule (\>3x10 to the ninth power) once daily for eight weeks.
  • Placebo Comparator: Individuals with ME/CFS without IBS on placebo
    Individuals with ME/CFS without IBS take a placebo, one capsule once daily for eight weeks.

Primary Outcome Measure

The Incidence of Intervention-Related Adverse Events [Safety] [ Time Frame: from baseline to the eight week visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Institute for Neuroimmune MedicineFort LauderdaleFlorida33314-7796
Oleksandra Shchebet
[email protected]
954-262-2896

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Institute for Neuroimmune Medicine· Fort Lauderdale, FL

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