A Phase 2 interventional study of Floradapt Intensive GI and Placebo in ME/CFS and IBS - Irritable Bowel Syndrome, sponsored by Nova Southeastern University. Recruiting at 1 site in United States. Open to participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-03-04.
Sponsored by Nova Southeastern University · Phase 2, Interventional, and Treatment
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Among 86 studies in Fatigue Syndrome, Chronic with a site in United States — 21 open to participants now, 24 under way, none of them phase 3. Fatigue Syndrome, Chronic · United States.
Among the 86 studies in Fatigue Syndrome, Chronic with a site in United States, this one is the 15th largest by planned enrollment of the 58 interventional ones that give a count, is one of 5 that started in 2022, is one of 12 in phase 2, reaches primary completion later than 5 of the 23 other live ones, and was the 70th registered.
264 studies on the registry are indexed under Fatigue Syndrome, Chronic; 62 are open to participants now.
Browse Fatigue Syndrome, Chronic studies →21 of the 86 studies in Fatigue Syndrome, Chronic with a site in United States are open now. Recruiting first, the newest first:
Fred Friedberg · Sites in United States
Ages 18–65
University of Alabama at Birmingham · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+
University of California, San Francisco · Sites in United States
Ages 18+ · Healthy volunteers
IMMUNOe Research Centers · Sites in United States
Ages 18–90
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 44 Fatigue Syndrome, Chronic studies recruiting now, 18 (41%) set no upper age limit and 20 (45%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.
This study: 45 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
86 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 17 · Phase 3 1 · Phase 4 5
First in 1994; this study’s year is marked. 5 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 60 across 178 interventional studies indexed under Fatigue Syndrome, Chronic.
Median enrollment 50 across the 58 interventional studies, 152 across the 26 observational. Of the 47 that completed or were terminated, 15 (32%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 86 have an industry lead sponsor. The 10 most frequent:
Nova Southeastern University is the lead sponsor of 80 studies on the registry; 18 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Nova Southeastern University has 1 study filed under Fatigue Syndrome, Chronic — fewer than ten, so there is no comparison to draw.
10 of the studies in Fatigue Syndrome, Chronic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06511050Icahn School of Medicine at Mount SinaiLumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome | 2026-12 |
| NCT06585254Icahn School of Medicine at Mount SinaitVNS in Long COVID-19 | 2026-12-31 |
| NCT04049331Seattle Institute for Biomedical and Clinical ResearchTestosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone | 2027-01-30 |
| NCT04542161Weill Medical College of Cornell UniversityAssessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome | 2027-04-30 |
| NCT07600320Icahn School of Medicine at Mount SinaiFareon Open Label Device Clinical Trial | 2027-04-30 |
Add all 10 to your calendar (.ics) → With an account.
Among the 86 studies in Fatigue Syndrome, Chronic with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Inclusion Criteria: eligible if all of the following apply:
Exclusion Criteria: ineligible if any of the following apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 take a placebo, one capsule once daily for eight weeks.
Other: Placebo
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 take a placebo, one capsule once daily for eight weeks.
Other: Placebo
one capsule daily for the eight week intervention
Also known as: i3.1
one capsule daily for the eight week intervention
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 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)
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: from baseline to the eight week visit
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 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.
Time frame: from the eight week visit to the 12 week visit
Plan to share: No — No plan available
No publications or documents are linked to this record.
Started Dec 2022 (actual). Primary completion is estimated for Feb 2026, 38 months after the start.
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Nova Southeastern University