IBS - Irritable Bowel Syndrome Clinical Trial
Official title:
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).
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. |
Country | Name | City | State |
---|---|---|---|
United States | Institute for Neuroimmune Medicine | Fort Lauderdale | Florida |
Lead Sponsor | Collaborator |
---|---|
Nova Southeastern University |
United States,
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 |
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