Using probiotics to treat Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the effectiveness of the i3.1 probiotic in participants aged 45 to 70 who meet the criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and may also have irritable bowel syndrome (IBS). The study is a randomized, placebo-controlled trial involving 100 participants, with half having co-morbid IBS. Participants will receive either the i3.1 probiotic or a placebo and will be assessed at baseline, eight weeks, and twelve weeks post-treatment to measure gastrointestinal inflammation and IBS severity.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria: 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 failure,
* Gastrointestinal surgery within six months of study entry,
* History of psychiatric disorder, alcohol or illicit drug abuse.

Where it's running

• Institute for Neuroimmune Medicine
  Fort Lauderdale, Florida, United States Recruiting

Study contacts

• Principal investigator: Nancy Klimas, MD — Nova Southeastern University, Institute for Neuroimmune Medicine
• Study coordinator: Nancy Klimas, MD
• Email: nklimas@nova.edu
• Phone: 9542622855

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.