Clinical trial NCT06211062: The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Official title: The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: ME/CFS
IBS - Irritable Bowel Syndrome
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).

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 or may not be diagnosed with the irritable bowel syndrome (IBS), according to the Rome IV criteria. In this study, we will evaluate using the i3.1 probiotic compared to placebo. This is a randomized, placebo-controlled trial with four study arms that will include 25 participants per arm: Individuals with ME/CFS with and without IBS, who will take either the active medication i3.1 or placebo.

Eligibility criteria: Inclusion Criteria: 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 Criteria: 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.

Primary outcomes:
measure: The Incidence of Intervention-Related Adverse Events [Safety]
timeFrame: from baseline to the eight week visit
measure: The Measurement of Biomarker Response to an Intervention in the Blood [Efficacy]
timeFrame: from baseline to the eight week visit
measure: level of CRP (C-reactive protein)
timeFrame: from baseline to the eight week visit
measure: The pro-inflammatory cytokines level e.g. IL-1, IL-6, and TNF-α
timeFrame: from baseline to the eight week visit
measure: The Symptom Severity Measurement [Efficacy]
timeFrame: from baseline to the eight week visit
Secondary outcomes:
measure: The Impact on the Irritable Bowel Syndrome (IBS) Severity
timeFrame: from baseline to the eight week
measure: The IBS-related Quality of Life Measurement
timeFrame: from the eight week visit to the 12 week visit
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Institute for Neuroimmune Medicine
state: Florida
Study officials:
affiliation: Nova Southeastern University, Institute for Neuroimmune Medicine
name: Nancy Klimas, MD
role: PRINCIPAL_INVESTIGATOR
References: