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

NCT06211062 | Recruiting Phase 2 DMC

• 1 other identifier: 2020-631
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

ME/CFS; IBS - Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (5)

• The Incidence of Intervention-Related Adverse Events [Safety]

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

  from baseline to the eight week visit

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

  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)

  from baseline to the eight week visit

• level of CRP (C-reactive protein)

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

  from baseline to the eight week visit

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

  The Measurement of Biomarker Response : cytokine panel.

  from baseline to the eight week visit

• The Symptom Severity Measurement [Efficacy]

  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).

  from baseline to the eight week visit

Secondary Outcomes (2)

• The Impact on the Irritable Bowel Syndrome (IBS) Severity

  from baseline to the eight week

• The IBS-related Quality of Life Measurement

  from the eight week visit to the 12 week visit

Study Arms (4)

Individuals with ME/CFS with IBS on active medication

ACTIVE COMPARATOR

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

Individuals with ME/CFS with IBS on placebo

PLACEBO COMPARATOR

Individuals with ME/CFS with IBS take a placebo, one capsule once daily for eight weeks.

Other: Placebo

Individuals with ME/CFS without IBS on active medication

ACTIVE COMPARATOR

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

Individuals with ME/CFS without IBS on placebo

PLACEBO COMPARATOR

Individuals with ME/CFS without IBS take a placebo, one capsule once daily for eight weeks.

Other: Placebo

Interventions

Floradapt Intensive GI DRUG

one capsule daily for the eight week intervention

Also known as: i3.1

Individuals with ME/CFS with IBS on active medication; Individuals with ME/CFS without IBS on active medication

Placebo OTHER

one capsule daily for the eight week intervention

Individuals with ME/CFS with IBS on placebo; Individuals with ME/CFS without IBS on placebo

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (1)

Institute for Neuroimmune Medicine

Fort Lauderdale, Florida, 33314-7796, United States

RECRUITING

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Nancy Klimas, MD

  Nova Southeastern University, Institute for Neuroimmune Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy Klimas, MD

CONTACT

9542622855; nklimas@nova.edu

Devra Cohen, MPH

CONTACT

9542621487; dcohen1@nova.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: January 18, 2024
• Study Start: December 20, 2022
• Primary Completion: February 24, 2026
• Study Completion: February 24, 2026
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)