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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	45 Years - 70 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06211062
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Nova Southeastern University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Nancy Klimas, MD
Principal Investigator Affiliation	Nova Southeastern University, Institute for Neuroimmune Medicine
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	ME/CFS, IBS - Irritable Bowel Syndrome

Additional Details

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.

Arms & Interventions

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.

Interventions

Drug: - Floradapt Intensive GI

one capsule daily for the eight week intervention

Other: - Placebo

one capsule daily for the eight week intervention

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Institute for Neuroimmune Medicine, Fort Lauderdale, Florida

Status

Recruiting

Address

Institute for Neuroimmune Medicine

Fort Lauderdale, Florida, 33314-7796

Site Contact

Oleksandra Shchebet

[email protected]

954-262-2896

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