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

IBS - Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06211062
• Other study ID #: 2020-631
• Status: Recruiting
• Phase: Phase 2
• Start date: December 20, 2022
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Nova Southeastern University
• Contact: Nancy Klimas, MD
• Phone: 9542622855
• Email: nklimas[@]nova.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Encephalomyelitis
• Fatigue Syndrome, Chronic
• IBS - Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• ME/CFS
• Syndrome

Intervention

Drug:
• Floradapt Intensive GI
one capsule daily for the eight week intervention

Other:
• Placebo
one capsule daily for the eight week intervention

Locations

Country	Name	City	State
United States	Institute for Neuroimmune Medicine	Fort Lauderdale	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nova Southeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	The pro-inflammatory cytokines level e.g. IL-1, IL-6, and TNF-a	The Measurement of Biomarker Response : cytokine panel.	from baseline to the eight week visit
Primary	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	The Impact on the Irritable Bowel Syndrome (IBS) Severity	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.	from baseline to the eight week
Secondary	The IBS-related Quality of Life Measurement	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.	from the eight week visit to the 12 week visit