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

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ClinicalTrials.gov Identifier: NCT06211062
Recruitment Status : Recruiting
First Posted : January 18, 2024
Last Update Posted : January 18, 2024
Sponsor:
Information provided by (Responsible Party):
Nova Southeastern University

Study Description
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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).

Condition or disease Intervention/treatment Phase
ME/CFS IBS - Irritable Bowel Syndrome Drug: Floradapt Intensive GI Other: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-blinded
Primary Purpose: Treatment
Official Title: The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Actual Study Start Date : December 20, 2022
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Floradapt Intensive GI
one capsule daily for the eight week intervention
Other Name: i3.1
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.
 Other: Placebo
one capsule daily for the eight week intervention
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.
 Drug: Floradapt Intensive GI
one capsule daily for the eight week intervention
Other Name: i3.1
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.
 Other: Placebo
one capsule daily for the eight week intervention


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06211062


Contacts
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Contact: Nancy Klimas, MD 9542622855 nklimas@nova.edu
Contact: Devra Cohen, MPH 9542621487 dcohen1@nova.edu

Locations
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United States, Florida
Institute for Neuroimmune Medicine Recruiting
Fort Lauderdale, Florida, United States, 33314-7796
Contact: Oleksandra Shchebet    954-262-2896    kanekastudy@nova.edu   
Sponsors and Collaborators
Nova Southeastern University
Investigators
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Principal Investigator: Nancy Klimas, MD Nova Southeastern University, Institute for Neuroimmune Medicine
More Information
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Responsible Party: Nova Southeastern University
ClinicalTrials.gov Identifier: NCT06211062    
Other Study ID Numbers: 2020-631
First Posted: January 18, 2024    Key Record Dates
Last Update Posted: January 18, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Encephalomyelitis
Fatigue Syndrome, Chronic
Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Muscular Diseases
Musculoskeletal Diseases
Neuroinflammatory Diseases
Nervous System Diseases
Neuromuscular Diseases
Chronic Disease
Disease Attributes
Central Nervous System Infections
Infections
Central Nervous System Diseases