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

Launched by NOVA SOUTHEASTERN UNIVERSITY · Jan 17, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a specific probiotic called i3.1 to see if it can help people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and possibly Irritable Bowel Syndrome (IBS). Researchers want to find out if this probiotic can reduce inflammation in the gut and improve overall health, particularly how it affects symptoms of IBS. The study will involve 100 participants aged 45 to 70, half of whom will also have IBS. Participants will either receive the i3.1 probiotic or a placebo (a non-active treatment) and will be monitored for changes over a total of 12 weeks.

To be eligible for the study, participants must meet certain criteria, including having a confirmed diagnosis of ME/CFS and, for some, IBS. They must be able to give consent and participate in follow-up surveys. However, people who have taken probiotics or antibiotics recently, are pregnant or breastfeeding, or have certain medical conditions will not be eligible. If you choose to participate, you'll be part of a study that aims to improve understanding and treatment of these challenging conditions, and you'll have the opportunity to help advance medical knowledge.

Gender

ALL

Eligibility criteria

• 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.