Back to search results

Probiotics for ME/CFS and IBS

This study is looking at how a probiotic called Floradapt Intensive GI might help people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Irritable Bowel Syndrome (IBS). Researchers want to see if taking one capsule daily for eight weeks can reduce gut inflammation and improve IBS symptoms. You might be able to join if you are between 45 and 70 years old, have ME/CFS (diagnosed by specific criteria), and potentially also have IBS. The study will measure safety by tracking any side effects and effectiveness by looking at blood markers like C-reactive protein (CRP). The current status of this study is unclear, and it plans to enroll 100 participants.

Study design
This is a randomized, placebo-controlled study with 100 participants. It has four groups: people with ME/CFS with or without IBS, who will receive either Floradapt Intensive GI or a placebo.
What's involved
Participants will take one capsule daily for eight weeks. Measurements will be taken from the start of the study until the eight-week visit.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the start of the study until the eight-week visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06211062

The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Recruiting
PHASE2Ages 45–70InterventionalTreatment
Nova Southeastern University
~100 participants
Updated 2025-03-04 on ClinicalTrials.gov
What's tested:Floradapt Intensive GIPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The Incidence of Intervention-Related Adverse Events [Safety]
Measured over from baseline to the eight week visit
+4 more outcomes measured

Conditions

ME/CFS
IBS - Irritable Bowel Syndrome

Explore related trials

Chronic Fatigue SyndromeIrritable Bowel Syndrome

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Nancy Klimas, MD · PRINCIPAL_INVESTIGATOR · Nova Southeastern University, Institute for Neuroimmune Medicine

Who to contact

Nancy Klimas, MD
[email protected]
9542622855
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • The Incidence of Intervention-Related Adverse Events [Safety]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]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)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-αfrom baseline to the eight week visit

    The Measurement of Biomarker Response : cytokine panel.

  • The Symptom Severity Measurement [Efficacy]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).