The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age45-70
SponsorNova Southeastern University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Floradapt Intensive GI
Drugone capsule daily for the eight week intervention
Placebo
Other interventionone capsule daily for the eight week intervention
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: Individuals with ME/CFS with IBS on active medicationActive comparator 1 intervention
Group B: Individuals with ME/CFS with IBS on placeboPlacebo comparator 1 intervention
Group C: Individuals with ME/CFS without IBS on active medicationActive comparator 1 intervention
Group D: Individuals with ME/CFS without IBS on placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
from baseline to the eight week visit2
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)
Time frame
from baseline to the eight week visit3
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)
Time frame
from baseline to the eight week visit4
The pro-inflammatory cytokines level e.g. IL-1, IL-6, and TNF-α
The Measurement of Biomarker Response : cytokine panel.
Time frame
from baseline to the eight week visitSecondary outcomes
1
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.
Time frame
from baseline to the eight week2
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.
Time frame
from the eight week visit to the 12 week visitSponsors and contacts
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Source ClinicalTrials.gov