ME/CFSPhase 2NCT06211062
The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
A Phase 2 study testing Floradapt Intensive GI in people with ME/CFS and IBS - Irritable Bowel Syndrome, run by Nova Southeastern University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- ME/CFS, IBS - Irritable Bowel Syndrome
- What is being tested?
- Floradapt Intensive GI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2022to 24 Feb 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Institute for Neuroimmune Medicine
Fort Lauderdale, Florida, 33314-7796
Oleksandra Shchebet, 954-262-2896, kanekastudy@nova.edu
About this study
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).
Read the detailed 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.
- Conditions
- ME/CFS, IBS - Irritable Bowel Syndrome
- Being tested
- Floradapt Intensive GI, Placebo
- Medical subject headings
- Fatigue Syndrome, Chronic, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Floradapt Intensive GIDrug
Also called i3.1
one capsule daily for the eight week intervention
PlaceboOther
one capsule daily for the eight week intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Floradapt Intensive GI |
| 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. Receives: Other: Placebo |
| 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. Receives: Drug: Floradapt Intensive GI |
| 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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).
Measured: from baseline to the eight week visit
Secondary outcomes (2)
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.
Measured: 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.
Measured: from the eight week visit to the 12 week visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start20 Dec 2022
- Primary completion24 Feb 2026 (estimated)
- Study completion24 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ME/CFSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy Klimas, MD, Principal investigator, Nova Southeastern University, Institute for Neuroimmune Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211062
- Sponsor's protocol ID
- 2020-631
- Status last verified
- Mar 2025
- First submitted
- 1 Aug 2023
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan available
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
- ClinicalTrials.gov ID
- NCT06211062
- Acronym / sponsor ID
- 2020-631
- Conditions
- ME/CFS, IBS - Irritable Bowel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 24 Feb 2026 (estimated)
- Study completion
- 24 Feb 2026 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Individuals with ME/CFS with IBS on active medication | Active comparator | Drug: Floradapt Intensive GIIndividuals 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. |
| Individuals with ME/CFS with IBS on placebo | Placebo comparator | Other: PlaceboIndividuals with ME/CFS with IBS take a placebo, one capsule once daily for eight weeks. |
| Individuals with ME/CFS without IBS on active medication | Active comparator | Drug: Floradapt Intensive GIIndividuals 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. |
| Individuals with ME/CFS without IBS on placebo | Placebo comparator | Other: PlaceboIndividuals with ME/CFS without IBS take a placebo, one capsule once daily for eight weeks. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Floradapt Intensive GIAlso: i3.1one capsule daily for the eight week intervention | Drug | Individuals with ME/CFS with IBS on active medication, Individuals with ME/CFS without IBS on active medication |
| Placeboone capsule daily for the eight week intervention | Other | Individuals with ME/CFS with IBS on placebo, Individuals with ME/CFS without IBS on placebo |
Primary outcome
The Incidence of Intervention-Related Adverse Events [Safety]
Time frame: from baseline to the eight week visit
Safety will be assessed by documenting the frequency and severity of adverse events using a standardized form at each visit.
The Measurement of Biomarker Response to an Intervention in the Blood [Efficacy]
Time frame: from baseline to the eight week visit
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)
level of CRP (C-reactive protein)
Time frame: from baseline to the eight week visit
CRP (C-reactive protein) will be measured at baseline and the eight-week visit (The Measurement of Biomarker Response)
The pro-inflammatory cytokines level e.g. IL-1, IL-6, and TNF-α
Time frame: from baseline to the eight week visit
The Measurement of Biomarker Response : cytokine panel.
The Symptom Severity Measurement [Efficacy]
Time frame: from baseline to the eight week visit
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).
2 secondary outcomes
The Impact on the Irritable Bowel Syndrome (IBS) Severity
Time frame: from baseline to the eight week
The IBS-related Quality of Life Measurement
Time frame: from the eight week visit to the 12 week visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: No. No plan available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nancy Klimas, MD principal investigator
Nova Southeastern University, Institute for Neuroimmune Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Floradapt Intensive GI in people with ME/CFS and IBS - Irritable Bowel Syndrome, run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Klimas, MD (9542622855, nklimas@nova.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of Intervention-Related Adverse Events [Safety] (time frame: from baseline to the eight week visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.