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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Floradapt Intensive GI | Drug | one capsule daily for the eight week intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria: eligible if all of the following apply:
Exclusion Criteria: ineligible if any of the following apply:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nancy Klimas, MD | Contact | 9542622855 | nklimas@nova.edu | |
| Devra Cohen, MPH | Contact | 9542621487 | dcohen1@nova.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nancy Klimas, MD | Nova Southeastern University, Institute for Neuroimmune Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Neuroimmune Medicine | Recruiting | Fort Lauderdale | Florida | 33314-7796 | United States |
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| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
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Double-blinded
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| Placebo | Other | one capsule daily for the eight week intervention |
|
| from baseline to the eight week |
| 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 |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |