Probiotics for Chronic Fatigue Syndrome

Overseen By Devra Cohen, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Nova Southeastern University

Must not be taking: Probiotics, Antibiotics

Disqualifiers: Pregnancy, Celiac, IBD, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the i3.1 probiotic (also known as Intensive GI i3.1 or Barisentials Probiotic) can reduce gut inflammation and improve symptoms in people with chronic fatigue syndrome (CFS), with or without irritable bowel syndrome (IBS). It will assess the probiotic's effect on gut health and IBS severity by comparing it to a placebo (a pill with no active ingredient) over 12 weeks. Eligible participants should have a CFS diagnosis, and some should also exhibit IBS symptoms like frequent diarrhea or alternating bowel habits. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

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.

Is there any evidence suggesting that the i3.1 probiotic is likely to be safe for humans?

Research has shown that the i3.1 probiotic is generally safe. In earlier studies, participants experienced no major negative effects on digestion or the immune system. The probiotic was well-tolerated and did not cause serious health issues. Although this trial is in an early stage, focusing primarily on safety, results so far suggest that the i3.1 probiotic could be a safe choice for potential participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic fatigue syndrome?

Researchers are excited about the i3.1 probiotic for Chronic Fatigue Syndrome (CFS) because it offers a novel approach compared to traditional treatments like cognitive behavioral therapy and graded exercise therapy. Unlike these standard therapies, i3.1 harnesses the power of probiotics to potentially improve gut health, which might be linked to CFS symptoms. This treatment specifically targets the gut microbiome, offering a new mechanism of action that could address both CFS and Irritable Bowel Syndrome (IBS) symptoms in some patients. By focusing on gut health, i3.1 represents a promising alternative that could provide relief where other treatments have fallen short.

What evidence suggests that the i3.1 probiotic might be an effective treatment for ME/CFS?

Research suggests that the i3.1 probiotic, which participants in this trial may receive, might help reduce gut inflammation in people with ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome), potentially leading to improved symptoms. Studies have shown that probiotics can enhance the gut-brain connection, which may benefit ME/CFS patients, especially those with irritable bowel syndrome (IBS). Some early findings indicate that targeting the gut with probiotics might help reduce fatigue, boost mood, and improve overall quality of life in people with post-infectious fatigue, a condition similar to ME/CFS. Although more research is needed, these initial results offer promise for those looking to manage their symptoms. ^{1 3 6 7 8}

Who Is on the Research Team?

Nancy Klimas, MD

Principal Investigator

Nova Southeastern University, Institute for Neuroimmune Medicine

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• i3.1 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.

How Is the Trial Designed?

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 European Union, United States, Canada for the following indications:

Approved in European Union as Intensive GI i3.1 for:

• Irritable Bowel Syndrome (IBS)
• Gastrointestinal inflammation

Approved in United States as Barisentials Probiotic for:

• Irritable Bowel Syndrome (IBS)
• Gastrointestinal inflammation
• Visceral pain

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

Probiotics, while generally considered safe, can pose significant risks including systemic infections, gastrointestinal issues, and immune system stimulation, particularly in vulnerable populations such as infants, the elderly, and immunocompromised individuals.

The review highlights the need for careful evaluation of the risk-benefit ratio of probiotics before recommending their use, given the variety of adverse effects reported across different studies and case reports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reappraisal of probiotics' safety in human. Sotoudegan, F., Daniali, M., Hassani, S., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06211062

Study Details | The Use of Directed Probiotics in ME/CFS This clinical study aims to evaluate the use of i3.1 probiotic in participants who meet the Institute of Medicine (Canadian Consensus Criteria) case ...

2. withpower.com withpower.com/trial/phase-2-mecfs-11-2022-51344

Probiotics for Chronic Fatigue Syndrome 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.

3. app.trialscreen.org app.trialscreen.org/trials/phase-2-use-directed-probiotics-cfs-myalgic-encephalomyelitis-chronic-trial-nct06211062

The Use of Directed Probiotics in ME/CFS This study aims to evaluate the effectiveness of a probiotic supplement (i3.1) in reducing gastrointestinal inflammation and improving symptoms of irritable ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10221065/

Positive Effects of Probiotic Therapy in Patients with Post ... Post-infectious fatigue is a common complication that can lead to decreased physical efficiency, depression, and impaired quality of life.

5. ctv.veeva.com ctv.veeva.com/study/the-use-of-directed-probiotics-in-me-cfs-myalgic-encephalomyelitis-chronic-fatigue-syndrome

The Use of Directed Probiotics in ME/CFS - ClinicalTrials.Veeva This clinical study aims to evaluate the use of i3.1 probiotic in participants who meet the Institute of Medicine (Canadian Consensus ...

6. memphis.edu memphis.edu/healthsciences/pdfs/2024-safety-and-efficacy-of-a-probiotic-cocktail-containing-p-acidilactici-and-l-.pdf

Safety and efficacy of a probiotic cocktail containing Under the current study conditions, the probiotic was safe to use, and did not affect gut- or immune-associated parameters, or intestinal ...

7. nova.edu nova.edu/inim/research-studies/me-cfs.html

ME/CFS Research This study aimed to use the probiotic Floradapt Intensive GI (other name i3.1), to reduce gastrointestinal (GI) inflammation and normalize the GI, to ...

8. cdnsciencepub.com cdnsciencepub.com/doi/abs/10.1139/apnm-2023-0449

Safety and efficacy of a probiotic cocktail containing P. ... This study assessed safety and efficacy of a probiotic in altering the intestinal milieu and mitigating gastrointestinal symptoms (GIS) in endurance runners.