Probiotics for Chronic Fatigue Syndrome

Recruiting in Palo Alto (17 mi)

Overseen by Nancy Klimas, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Nova Southeastern University

Must not be taking: Probiotics, Antibiotics

Disqualifiers: Pregnancy, Celiac, IBD, others

Prior Safety Data

Approved in 3 Jurisdictions

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. ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

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. ^{1 2 4 8 9}

Research Team

Nancy Klimas, MD

Principal Investigator

Nova Southeastern University, Institute for Neuroimmune Medicine

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

Able to provide consent to study

Agrees to participate in online surveys and follow-up visits

I have been diagnosed with IBS that mainly causes diarrhea or changes in bowel habits.

Exclusion Criteria

History of psychiatric disorder, alcohol or illicit drug abuse

Probiotics in the past eight weeks

Pregnancy or lactating women

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the i3.1 probiotic or placebo for eight weeks

8 weeks

Weekly visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit at 12 weeks

Treatment Details

Interventions

• i3.1 probiotic (Probiotic)

Trial Overview The study tests if a probiotic called i3.1 can reduce GI inflammation and improve brain-GI system interaction in ME/CFS patients, some with IBS. Half will receive the probiotic, half a placebo, over an eight-week period followed by assessments.

Participant Groups

Group I: Individuals with ME/CFS with IBS on active medication Active Control 1 Intervention

Individuals with ME/CFS with IBS take Floradapt Intensive GI (another name i3.1), one high dose capsule (\>3x10 to the ninth power) once daily for eight weeks.

Group II: Individuals with ME/CFS without IBS on active medication Active Control 1 Intervention

Individuals with ME/CFS without IBS take Floradapt Intensive GI (another name i3.1), one high dose capsule (\>3x10 to the ninth power) once daily for eight weeks.

Group III: Individuals with ME/CFS with IBS on placebo Placebo Group 1 Intervention

Individuals with ME/CFS with IBS take a placebo, one capsule once daily for eight weeks.

Group IV: Individuals with ME/CFS without IBS on placebo Placebo Group 1 Intervention

Individuals with ME/CFS without IBS take a placebo, one capsule once daily for eight weeks.

i3.1 probiotic is already approved in Canada for the following indications:

Approved in Canada as Intensive GI i3.1 for:

• Irritable Bowel Syndrome (IBS)
• Gastrointestinal inflammation

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials

103

Recruited

12,000+

Dr. George L. Hanbury II

Nova Southeastern University

Chief Executive Officer since 2011

PhD in Higher Education Administration from Nova Southeastern University

Dr. Gary S. Margules

Nova Southeastern University

Chief Medical Officer since 2010

MD from University of Miami

Findings from Research

In a study involving 15 patients with chronic fatigue syndrome (CFS), the intake of specific probiotics did not lead to significant changes in fatigue or physical activity scores, but some patients reported health improvements.

Despite no major changes in gastrointestinal microflora, the study suggests that probiotics may have potential benefits for CFS patients, particularly in improving neurocognitive functions, warranting further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of supplement with lactic-acid producing bacteria on fatigue and physical activity in patients with chronic fatigue syndrome. Sullivan, A., Nord, CE., Evengård, B.[2022]

A systematic review of 25 studies found that while probiotics have excellent evidence for improving irritable bowel syndrome (IBS) symptoms, the evidence for their effectiveness in treating gastrointestinal symptoms in chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is poor and limited.

Most studies focused on IBS rather than CFS/ME, indicating a need for more standardized and higher-quality research on probiotic interventions specifically for CFS/ME patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Probiotic Interventions for Gastrointestinal Symptoms and Irritable Bowel Syndrome in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME). Corbitt, M., Campagnolo, N., Staines, D., et al.[2020]

A systematic review of randomized controlled trials identified two high-quality studies involving 83 patients with chronic fatigue syndrome (CFS) that showed probiotics, specifically Lactobacillus casei and Bifidobacterium infantis, can significantly reduce anxiety and inflammatory biomarkers over an 8-week treatment period.

The findings suggest that while probiotics may help modulate anxiety and inflammation in CFS patients, the overall evidence for their effectiveness in treating fibromyalgia syndrome (FMS) and CFS is still limited, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are probiotic treatments useful on fibromyalgia syndrome or chronic fatigue syndrome patients? A systematic review. Roman, P., Carrillo-Trabalón, F., Sánchez-Labraca, N., et al.[2019]

A combination of probiotics was found to potentially improve the immune response and reduce inflammation in patients with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME), suggesting a beneficial effect on their overall well-being.

The study, which involved clinical and laboratory evaluations before and after probiotic treatment, reported no significant adverse effects, except for one patient who experienced a flare-up of symptoms, indicating that probiotics may be a safe intervention for CFS/ME.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modification of Immunological Parameters, Oxidative Stress Markers, Mood Symptoms, and Well-Being Status in CFS Patients after Probiotic Intake: Observations from a Pilot Study. Venturini, L., Bacchi, S., Capelli, E., et al.[2022]

In a pilot study of 70 patients with post-infectious fatigue, those receiving a multi-strain probiotic showed significantly greater improvements in fatigue severity and mood compared to the placebo group after 6 months, with notable reductions in fatigue and depression scores.

Probiotics also led to significant enhancements in overall quality of life, while the placebo group only experienced limited improvements, suggesting that probiotics may effectively modulate the gut-brain axis to benefit patients suffering from post-infectious fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive Effects of Probiotic Therapy in Patients with Post-Infectious Fatigue. Obermoser, K., Brigo, N., Schroll, A., et al.[2023]

Probiotics have shown promise in various populations, including critically ill patients, but concerns about their safety arose after a study reported high mortality rates, although no causal link was established.

Despite ongoing debates, a substantial amount of evidence suggests that probiotics are generally safe and may even reduce adverse events compared to controls, highlighting the need for standardized safety reporting in clinical studies to strengthen their safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dealing with the remaining controversies of probiotic safety. van den Nieuwboer, M., Claassen, E.[2020]

In a pilot study of 39 patients with chronic fatigue syndrome, those who took the probiotic Lactobacillus casei strain Shirota showed a significant reduction in anxiety symptoms compared to the placebo group after two months.

The study also found an increase in beneficial gut bacteria (Lactobacillus and Bifidobacteria) in patients taking the probiotic, suggesting a potential link between gut health and mood regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled pilot study of a probiotic in emotional symptoms of chronic fatigue syndrome. Rao, AV., Bested, AC., Beaulne, TM., et al.[2022]

The study suggests that 'Nagipol', a dietary supplement made from beer yeasts, can improve clinical status in patients with chronic fatigue syndrome (CFS) by positively affecting cognitive functions and normalizing blood biochemical parameters.

'Nagipol' is recommended as a preventive and therapeutic dietary addition for individuals with CFS, particularly those with excessive body mass and obesity, highlighting its potential role in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Biologically active food additives for correction of the chronic fatigue syndrome]. Dotsenko, VA., Mosiĭchuk, LV., Paramonov, AE.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of supplement with lactic-acid producing bacteria on fatigue and physical activity in patients with chronic fatigue syndrome. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Probiotic Interventions for Gastrointestinal Symptoms and Irritable Bowel Syndrome in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME). [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Are probiotic treatments useful on fibromyalgia syndrome or chronic fatigue syndrome patients? A systematic review. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Modification of Immunological Parameters, Oxidative Stress Markers, Mood Symptoms, and Well-Being Status in CFS Patients after Probiotic Intake: Observations from a Pilot Study. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Positive Effects of Probiotic Therapy in Patients with Post-Infectious Fatigue. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Reappraisal of probiotics' safety in human. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Dealing with the remaining controversies of probiotic safety. [2020]

8. England pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled pilot study of a probiotic in emotional symptoms of chronic fatigue syndrome. [2022]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Biologically active food additives for correction of the chronic fatigue syndrome]. [2020]