Probiotics for Chronic Fatigue Syndrome
Trial Summary
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have taken probiotics or antibiotics in the past eight weeks before joining.
What data supports the effectiveness of the treatment i3.1 probiotic, Intensive GI i3.1, Barisentials Probiotic for Chronic Fatigue Syndrome?
Some studies suggest that probiotics can help improve mood and reduce inflammation in Chronic Fatigue Syndrome (CFS) patients, and they have shown positive effects on fatigue and quality of life in post-infectious fatigue, which is related to CFS. However, the evidence specifically for probiotics in CFS is limited and more research is needed.12345
Is the probiotic treatment safe for humans?
Probiotics are generally considered safe for most people, but there are some risks, especially for infants, elderly, hospitalized patients, and those with weakened immune systems. In studies with chronic fatigue syndrome patients, probiotics were mostly well-tolerated, though one patient experienced a flare-up of symptoms. Overall, probiotics can have side effects like infections or immune system stimulation, so it's important to weigh the risks and benefits.12467
How does the i3.1 probiotic treatment differ from other treatments for chronic fatigue syndrome?
The i3.1 probiotic treatment is unique because it uses specific strains of beneficial bacteria to potentially improve gut health and immune function, which may help alleviate some symptoms of chronic fatigue syndrome. Unlike other treatments, it focuses on modifying the gut microbiome and reducing inflammation, which are thought to be linked to the condition.12489
Eligibility Criteria
This trial is for men and women aged 45-70 with ME/CFS as defined by the Canadian Consensus Criteria. It's also open to those who may have IBS according to Rome IV criteria. Participants should not be part of any other studies or have conditions that could interfere with this trial.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the i3.1 probiotic or placebo for eight weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- i3.1 probiotic (Probiotic)
i3.1 probiotic is already approved in European Union, United States, Canada for the following indications:
- Irritable Bowel Syndrome (IBS)
- Gastrointestinal inflammation
- Irritable Bowel Syndrome (IBS)
- Gastrointestinal inflammation
- Visceral pain
- Irritable Bowel Syndrome (IBS)
- Gastrointestinal inflammation