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NCT Number: NCT06211062

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 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).

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Key information

Conditions

ME/CFS Chronic Disease Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Gastrointestinal Diseases IBS - Irritable Bowel Syndrome Intestinal Diseases Irritable Bowel Syndrome Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institute for Neuroimmune Medicine

Fort Lauderdale, Florida, 33314-7796, United States

Location status: Recruiting

Location contact

Oleksandra Shchebet

CONTACT

[email protected]

954-262-2896

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Floradapt Intensive GI

Drug

one capsule daily for the eight week intervention

Other names: i3.1

Placebo

Other

one capsule daily for the eight week intervention

Primary outcomes

  1. The Incidence of Intervention-Related Adverse Events [Safety]

    Time frame: from baseline to the eight week visit

    Safety will be assessed by documenting the frequency and severity of adverse events using a standardized form at each visit.

  2. The Measurement of Biomarker Response to an Intervention in the Blood [Efficacy]

    Time frame: from baseline to the eight week visit

    The inflammation biomarkers panel will be measured at baseline and during the eight-week visit.

    Inflammation biomarkers analyses (such as zonulin, LPS (lipopolysaccharide) endotoxin, LBP (lipopolysaccharide-binding protein)

  3. level of CRP (C-reactive protein)

    Time frame: from baseline to the eight week visit

    CRP (C-reactive protein) will be measured at baseline and the eight-week visit (The Measurement of Biomarker Response)

  4. The pro-inflammatory cytokines level e.g. IL-1, IL-6, and TNF-α

    Time frame: from baseline to the eight week visit

    The Measurement of Biomarker Response : cytokine panel.

  5. The Symptom Severity Measurement [Efficacy]

    Time frame: from baseline to the eight week visit

    The symptom severity will be measured as a change of scores on the DePaul Symptom Questionnaire (DSQ) from baseline to eight-week visit. The severity and frequency are calculated on the Likert scale, where for severity 0 refers to symptoms not present, and 4 is for very severe, and for the frequency: 0 is for none of the time, and 4 is for all of the time. The score range is from 0 to 216. A higher score means a worse outcome (symptoms are present more often with more severity).

Secondary outcomes

  1. The Impact on the Irritable Bowel Syndrome (IBS) Severity

    Time frame: from baseline to the eight week

    The impact on the Irritable Bowel Syndrome (IBS) severity will be assessed by response to intervention based on the change in score on the IBS-SSS (Irritable Bowel Syndrome Symptom Severity Scale) questionnaire from a baseline visit to an eight-week visit. Scores response on a 100-point visual analogue scale range from 0 to 500. Subjects can be categorized as mild (75-175), moderate (175-300), or severe (>300) IBS. A decrease of 50 points is associated with a clinically meaningful improvement.

  2. The IBS-related Quality of Life Measurement

    Time frame: from the eight week visit to the 12 week visit

    The measurement will be provided using the IBS-QOL (the Irritable Bowel Syndrome Quality of Life Measurement) questionnaire every visit from baseline to week eight. Each item is related on the Likert scale, ranging from 1 to 5 (1 as "not at all", 5 as "extremely"). Total score ranges from 34 to 170; higher scores mean a lower life quality. A decrease of 10 points is a clinically meaningful improvement.

Study contacts

Contact information is provided by the study sponsor or research team.

Devra Cohen, MPH

CONTACT

[email protected]

9542621487

Nancy Klimas, MD

CONTACT

[email protected]

9542622855

Sponsors and collaborators

Lead sponsor

Nova Southeastern University

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 18, 2024
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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