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New treatment option for ME/CFS
Official title The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
ClinicalTrials.gov ID: NCT06211062
What this study is testing
What is Floradapt Intensive GI?
Floradapt Intensive GI is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for me/cfs.
Also referred to as i3.1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 70
You may be able to join if
- 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...
You likely can't join if
- 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...
- Gastrointestinal surgery within six months of study entry,
See the full eligibility 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.
- 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...
- Gastrointestinal surgery within six months of study entry,
- History of psychiatric disorder, alcohol or illicit drug abuse.
The study team makes the final eligibility decision.
Where it's taking place
- Fort Lauderdale, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fort Lauderdale, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.