Probiotics for Chronic Fatigue Syndrome
Palo Alto (17 mi)Overseen byNancy Klimas, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Nova Southeastern University
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).
Is the i3.1 probiotic a promising treatment for Chronic Fatigue Syndrome?The i3.1 probiotic shows potential as a treatment for Chronic Fatigue Syndrome. Some studies suggest that probiotics can improve mood and emotional symptoms, which are common in CFS. They may also help with gut health, which is often linked to CFS symptoms. However, more research is needed to confirm these benefits specifically for CFS.12348
What safety data exists for probiotics used in treating Chronic Fatigue Syndrome?The safety data for probiotics in treating Chronic Fatigue Syndrome (CFS) is limited and of poor quality. Some studies suggest probiotics can modify well-being and inflammatory markers in CFS patients without major adverse effects, although one case reported a flare-up of symptoms. General safety concerns for probiotics include systemic infections, gastrointestinal side effects, and immune system stimulation, especially in vulnerable populations. Overall, more standardized and high-quality research is needed to establish a strong safety profile for probiotics in CFS treatment.24678
What data supports the idea that Probiotics for Chronic Fatigue Syndrome (also known as: i3.1 probiotic, Intensive GI i3.1, Barisentials Probiotic) is an effective treatment?The available research shows mixed results for the effectiveness of probiotics in treating Chronic Fatigue Syndrome (CFS). One study found that probiotics improved neurocognitive functions in CFS patients, but did not significantly change fatigue or physical activity levels. Another study noted that probiotics reduced anxiety and inflammation in CFS patients, but overall evidence for their effectiveness in CFS is limited and of poor quality. However, probiotics have shown positive effects in related conditions like post-infectious fatigue, where they improved fatigue, mood, and quality of life more than a placebo. This suggests potential benefits, but more research is needed to confirm their effectiveness specifically for CFS.24589
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop your current medications. However, you cannot have taken probiotics or antibiotics in the past eight weeks.
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
I have been diagnosed with ME/CFS according to IOM criteria.
Exclusion Criteria
I do not have severe digestive, heart, brain, or liver conditions.
I have not had any gastrointestinal surgery in the last 6 months.
Treatment Details
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.
4Treatment groups
Active Control
Placebo Group
Group I: Individuals with ME/CFS with IBS on active medicationActive Control1 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 medicationActive Control1 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 placeboPlacebo Group1 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 placeboPlacebo Group1 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Institute for Neuroimmune MedicineFort Lauderdale, FL
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Who is running the clinical trial?
Nova Southeastern UniversityLead Sponsor
References
[Biologically active food additives for correction of the chronic fatigue syndrome]. [2020]The syndrome of chronic fatigue is a rather new pathology, included in ADS 10. There is no specific treatment. Vitamins and microelements are very important for the prevention and treatment of CFS. Of special significance are BAA on the basis of yarsts, which are universal in their biological chemical composition and contain high amounts of vitamins B, K and essential aminoacids. The aim this work is clinical diagnostic of "Nagipol" use, made on the basis of beer yeasts, for the prevention and treatment of CFS. Clinical-dietologic study showed that "Nagipol" biologically active additive, useful in CFS, prodvecins clinical status improvement in CFS, positively influencing cognitive CNS functions, symptoms of psychoemtional instability, normalizing blood biochemical parameters, can be recommended as one of the addition element in diet-therapy of patients with excessive body mass and otesitg with the associated CFS. Recommended "Nagipol" as preventive-medical dietetic means for this pathology.
Effect of supplement with lactic-acid producing bacteria on fatigue and physical activity in patients with chronic fatigue syndrome. [2022]Disturbances in intestinal microbial ecology and in the immune system of the host have been implicated as a part of the pathogenesis in chronic fatigue syndrome. Probiotic lactic acid producing bacteria have been shown to prevent and alleviate gastrointestinal disturbances and to normalize the cytokine profile which might be of an advantage for patients suffering from chronic fatigue syndrome. The aim of the study was to evaluate the effect of Lactobacillus paracasei ssp. paracasei F19, Lactobacillus acidophilus NCFB 1748 and Bifidobacterium lactis Bb12 on fatigue and physical activity in CFS patients. Fifteen patients fulfilling the criteria set by international researchers in the field at the US Centre for Disease Control and Prevention in 1994 for chronic fatigue syndrome, were included in the study. The patients had high fatigue severity scores and high disability scores. During the first two weeks baseline observations without treatment were assessed, succeeded by four weeks of intake of a probiotic product and a four-week follow-up period. The fatigue, health and physical activity was assessed by the use of the Visual Analogue Scales and the SF-12 Health Survey. Faecal samples were collected and the normal microflora was analysed. Neurocognitive functions improved during the study period while there were no significant changes in fatigue and physical activity scores. No major changes occurred in the gastrointestinal microflora. At the end of the study 6 of 15 patients reported that they had improved according to the assessment described. The findings in this study that improvement of health is possible to achieve should encourage further studies with interventions with probiotics in patients with CFS.
A randomized, double-blind, placebo-controlled pilot study of a probiotic in emotional symptoms of chronic fatigue syndrome. [2022]Chronic fatigue syndrome (CFS) is complex illness of unknown etiology. Among the broad range of symptoms, many patients report disturbances in the emotional realm, the most frequent of which is anxiety. Research shows that patients with CFS and other so-called functional somatic disorders have alterations in the intestinal microbial flora. Emerging studies have suggested that pathogenic and non-pathogenic gut bacteria might influence mood-related symptoms and even behavior in animals and humans. In this pilot study, 39 CFS patients were randomized to receive either 24 billion colony forming units of Lactobacillus casei strain Shirota (LcS) or a placebo daily for two months. Patients provided stool samples and completed the Beck Depression and Beck Anxiety Inventories before and after the intervention. We found a significant rise in both Lactobacillus and Bifidobacteria in those taking the LcS, and there was also a significant decrease in anxiety symptoms among those taking the probiotic vs controls (p = 0.01). These results lend further support to the presence of a gut-brain interface, one that may be mediated by microbes that reside or pass through the intestinal tract.
A Systematic Review of Probiotic Interventions for Gastrointestinal Symptoms and Irritable Bowel Syndrome in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME). [2020]Gastrointestinal (GI) symptoms and irritable bowel (IB) symptoms have been associated with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). The aim of this study was to conduct a systematic review of these symptoms in CFS/ME, along with any evidence for probiotics as treatment. Pubmed, Scopus, Medline (EBSCOHost) and EMBASE databases were searched to source relevant studies for CFS/ME. The review included any studies examining GI symptoms, irritable bowel syndrome (IBS) and/or probiotic use. Studies were required to report criteria for CFS/ME and study design, intervention and outcome measures. Quality assessment was also completed to summarise the level of evidence available. A total of 3381 publications were returned using our search terms. Twenty-five studies were included in the review. Randomised control trials were the predominant study type (n = 24). Most of the studies identified examined the effect of probiotic supplementation on the improvement of IB symptoms in IBS patients, or IB symptoms in CFS/ME patients, as well as some other significant secondary outcomes (e.g. quality of life, other gastrointestinal symptoms, psychological symptoms). The level of evidence identified for the use of probiotics in IBS was excellent in quality; however, the evidence available for the use of probiotic interventions in CFS/ME was poor and limited. There is currently insufficient evidence for the use of probiotics in CFS/ME patients, despite probiotic interventions being useful in IBS. The studies pertaining to probiotic interventions in CFS/ME patients were limited and of poor quality overall. Standardisation of protocols and methodology in these studies is required.
Are probiotic treatments useful on fibromyalgia syndrome or chronic fatigue syndrome patients? A systematic review. [2019]Evidence suggests that the gut microbiota might play an important role in fibromyalgia syndrome (FMS) and chronic fatigue syndrome (CFS). Our goal is to systematically review the reported effect of probiotic treatments in patients diagnosed with FMS or CFS. A systematic review was carried out using 14 databases (PubMed, Cochrane Library, Scopus, PsycINFO, and others) in February 2016 to search for randomised controlled trials (RCTs) and pilot studies of CFS or FMS patient, published in the last ten years (from 2006 to 2016). The Jadad scale was used to asseverate the quality of the clinical trials considered. Two studies (n=83) met the inclusion criteria, which were performed in CFS patients and both studies were considered as a 'High range of quality score'. The administration of Lactobacillus casei strain Shirota in CFS patients, over the course of 8 weeks, reduced anxiety scores. Likewise, this probiotic changed the faecal composition following 8 weeks of treatment. Additionally, the treatment with Bifidobacterium infantis 35624 in CFS patients, during the same period, reduced inflammatory biomarkers. The evidence about the usefulness of probiotics in CFS and FMS patients remains limited. The studied strains of probiotics have demonstrated a significant effect on modulating the anxiety and inflammatory processes in CFS patients. However, more experimental research, focusing mainly on the symptoms of the pathologies studied, is needed.
Reappraisal of probiotics' safety in human. [2019]Contrary to the safe usage of probiotics for years, their threat is still worthy of attention. Several risks have been explained or mentioned in the case reports, clinical trials and experimental studies. Due to a large number of probiotic products worldwide, the certainty of the safety of such products is a matter of concern. Current review appraises all the available information about a range of adverse effects by probiotics in different populations of consumers and almost all qualified investigations and reports, relevant to the adverse effects of probiotics. Furthermore, the effects of basic or original sources of probiotics were studied. The principally noticed adverse effects of probiotics are systemic infections, gastrointestinal side effects, skin complications, inflammation of endocardium, gene transfer from probiotics to the normal microbial flora, metabolic harmful impacts of probiotics, and immune system stimulation. The most at-risk groups consist of infants, elderly people, patients in hospitalized condition, and those with immunodeficiency due to a genetic or acquired disease. The existing evidence suggests careful evaluation of the risk-benefit ratio of probiotics prior to prescription or recommendation to use.
Dealing with the remaining controversies of probiotic safety. [2020]A clear safety profile of probiotics in clinical practice is essential in decision-making for all stakeholders and regulators. Probiotics have been investigated in different target populations, conditions and age groups. This also includes the use of probiotics in critically ill patients. Despite promising results reported with the use of probiotics and synbiotics, there is still a lively discussion regarding the proper and safe use of probiotics among physicians, researchers and regulators. This doubt and debate was sparked by the high incidence in mortality reported in a study with critically ill patients. Whereas no causal relationship has been established since, safety of probiotic has been questioned. In response, an overwhelming body of evidence suggesting that probiotics are safe has been compiled. Moreover, data indicates that probiotics reduce the number of adverse events compared to the control. However, due to a lack of standardised safety reporting in clinical studies, a strong evidence base on probiotic safety remains to be established. Here, we will discuss: (1) the rationale for using probiotics in the critically ill; (2) what happened during the Dutch Pancreatitis trial; (3) what are the known safety risks of probiotics based on the available data; and finally (4) how standardisation in safety reporting can drive probiotic innovation. Building a strong safety profile for probiotic strains will solidify its use in individuals that can benefit the most from microbial modulation.
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]The present study discusses about the effects of a combination of probiotics able to stimulate the immune system of patients affected by Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME). To this purpose, patients diagnosed according to Fukuda's criteria and treated with probiotics were analyzed by means of clinical and laboratory evaluations, before and after probiotic administrations. Probiotics were selected considering the possible pathogenic mechanisms of ME/CFS syndrome, which has been associated with an impaired immune response, dysregulation of Th1/Th2 ratio, and high oxidative stress with exhaustion of antioxidant reserve due to severe mitochondrial dysfunction. Immune and oxidative dysfunction could be related with the gastrointestinal (GI) chronic low-grade inflammation in the lamina propria and intestinal mucosal surface associated with dysbiosis, leaky gut, bacterial translocation, and immune and oxidative dysfunction. Literature data demonstrate that bacterial species are able to modulate the functions of the immune and oxidative systems and that the administration of some probiotics can improve mucosal barrier function, modulating the release of proinflammatory cytokines, in CFS/ME patients. This study represents a preliminary investigation to verifying the safety and efficacy of a certain combination of probiotics in CFS/ME patients. The results suggest that probiotics can modify the well-being status as well as inflammatory and oxidative indexes in CFS/ME patients. No adverse effects were observed except for one patient, which displayed a flare-up of symptoms, although all inflammatory parameters (i.e., cytokines, fecal calprotectin, ESR, and immunoglobulins) were reduced after probiotic intake. The reactivation of fatigue symptoms in this patient, whose clinical history reported the onset of CFS/ME following mononucleosis, could be related to an abnormal stimulation of the immune system as suggested by a recent study describing an exaggerated immune activation associated with chronic fatigue.
Positive Effects of Probiotic Therapy in Patients with Post-Infectious Fatigue. [2023]Post-infectious fatigue is a common complication that can lead to decreased physical efficiency, depression, and impaired quality of life. Dysbiosis of the gut microbiota has been proposed as a contributing factor, as the gut-brain axis plays an important role in regulating physical and mental health. This pilot study aimed to investigate the severity of fatigue and depression, as well as the quality of life of 70 patients with post-infectious fatigue who received a multi-strain probiotic preparation or placebo in a double-blind, placebo-controlled trial. Patients completed questionnaires to assess their fatigue (fatigue severity scale (FSS)), mood (Beck Depression Inventory II (BDI-II)), and quality of life (short form-36 (SF-36)) at baseline and after 3 and 6 months of treatment. Routine laboratory parameters were also assessed, including immune-mediated changes in tryptophan and phenylalanine metabolism. The intervention was effective in improving fatigue, mood, and quality of life in both the probiotic and placebo groups, with greater improvements seen in the probiotic group. FSS and BDI-II scores declined significantly under treatment with both probiotics and placebo, but patients who received probiotics had significantly lower FSS (p < 0.001) and BDI-II (p < 0.001) scores after 6 months. Quality of life scores improved significantly in patients who received probiotics (p < 0.001), while patients taking a placebo only saw improvements in the "Physical limitation" and "Energy/Fatigue" subcategories. After 6 months neopterin was higher in patients receiving placebo, while no longitudinal changes in interferon-gamma mediated biochemical pathways were observed. These findings suggest that probiotics may be a promising intervention for improving the health of patients with post-infectious fatigue, potentially through modulating the gut-brain axis.