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

Sponsored by Nova Southeastern University

About this trial

Last updated a year ago

Study ID

2020-631

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

45 to 70 Years

All Sexes

Trial Timing

Ended 3 months ago

What is this trial about?

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? * how well is it working on IBS severity? The study sample is 100 male and female participants aged 45 to 70 years with ME/CFS (per the Canadian Consensus Criteria); one-half of the participants will have co-morbid IBS (per Rome IV criteria). Participants will receive an i3.1 or a placebo and be assessed at baseline, at eight weeks, and at 12 weeks (four weeks post-treatment completion).

What are the Participation Requirements?

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.