ME/CFS study: Floradapt Intensive GI
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, taken by mouth once daily, 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
- The study wants to see if the i3.1 probiotic can lower gut inflammation, improve gut‑brain interaction, and reduce IBS symptoms in people with ME/CFS.
- Who it's for
- Adults aged 45 to 70 who meet the Canadian Consensus Criteria for ME/CFS; about half also have IBS.
- What's involved
- Participants will take either the i3.1 probiotic or a placebo for eight weeks and will have clinic visits and tests at the start, after eight weeks, and four weeks after treatment ends.
- Time commitment
- The trial lasts about 12 weeks with three study visits.
- 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
- 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...
- agrees to participate in online surveys and follow-up visits.
You likely can't join if
- 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,
- History of psychiatric disorder, alcohol or illicit drug abuse.
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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?
This study is enrolling now at Fort Lauderdale, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.