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Background & Aims: The aim of this study was to investigate the effectiveness of oral treatment with a nonviable probiotic lysate (BL) of Escherichia coli (DSM 17252) and Enterococcus faecalis (DSM 16440) in patients with irritable bowel syndrome (IBS)., Methods: A phase IV, randomized, double-blind, placebo-controlled, multicenter (30 study sites), parallel group study was conducted in 389 patients of both sexes with IBS according to Rome III criteria. The treatment period was 26 weeks. The participants were allocated to either placebo or BL after a 2-week baseline period. The primary outcome was based on the European Medicines Agency IBS guideline: improvement in global assessment (GAI) and improvement in abdominal pain., Results: Patients (BL, n = 191; placebo, n = 198) had similar baseline values and dropout rates. Overall, the response was similar between BL and placebo for IBS-GAI (17.4% and 14.4%, respectively; P = ·4787) and abdominal pain (42.0% and 35.4%, respectively; P = ·1419). Some secondary outcome measures and sensitivity analyses pointed toward potentially higher sensitivity of the abdominal pain measures in diarrhea-predominant IBS (IBS-D) but not the other subtypes. For the GAI, no subgroup differences were detected. For IBS-D, post hoc analyses for abdominal pain response over time and stool consistency showed potentially promising effects of BL. Finally, the treatment with BL was well-tolerated., Conclusions: BL is not effective across all IBS subtypes. However, BL may offer a treatment option for IBS-D that needs verification by an adequately powered drug trial; EudraCT-No.: 2012-002741-38., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The gut microbiota impacts on central nervous system (CNS) function via the microbiota-gut-brain axis. Thus, therapeutics targeting the gut microbiota such as probiotics have the potential for improving mental health. This meta-analysis synthesizes the evidence regarding the impacts of probiotics on psychological well-being, psychiatric symptoms and CNS functioning., Methods: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were applied for executing this review using the databases PubMed, Web of Science and Cochrane Library. The data were summarized at qualitative and quantitative level., Results: Fifty-four randomized placebo-controlled studies were included, of which 30 were eligible for meta-analysis. If investigated, the probiotics mostly exerted effects on CNS function. Most probiotics did not affect mood, stress, anxiety, depression and psychiatric distress when compared to placebo at the qualitative level. At quantitative level, depression and psychiatric distress improved slightly in the probiotic condition (depression: mean difference -0.37 (95% CI: -0.55, -0.20); p ≤ 0.0001; psychiatric distress: mean difference -0.33 (95% CI: -0.53, -0.13); p = 0.001)., Conclusions: To date it is unclear to which extent and in which specific areas next generation probiotics selected and developed for their ability to improve psychiatric condition and potentially other CNS functions are promising.

The gastrointestinal (GI) microbiota plays an important role in health and disease, including brain function and behavior. Bariatric surgery (BS) has been reported to result in various changes in the GI microbiota, therefore demanding the investigation of the impact of GI microbiota on treatment success. The goal of this systematic review was to assess the effects of BS on the microbiota composition in humans and other vertebrates, whether probiotics influence postoperative health, and whether microbiota and psychological and behavioral factors interact. A search was conducted using PubMed and Web of Science to find relevant studies with respect to the GI microbiota and probiotics after BS, and later screened for psychological and behavioral parameters. Studies were classified into groups and subgroups to provide a clear overview of the outcomes. Microbiota changes were further assessed for whether they were specific to BS in humans through the comparison to sham operated controls in other vertebrate studies. Changes in alpha diversity appear not to be specific, whereas dissimilarity in overall microbial community structure, and increases in the abundance of the phylum Proteobacteria and Akkermansia spp. within the phylum Verrucomicrobia after surgery were observed in both human and other vertebrates studies and may be specific to BS in humans. Human probiotic studies differed regarding probiotic strains and dosages, however it appeared that probiotic interventions were not superior to a placebo for quality of life scores or weight loss after BS. The relationship between GI microbiota and psychological diseases in this context is unclear due to insufficient available data.

Introduction: Several studies suggest that gut microbiota may play an important role in allergic diseases. The present trial aims to examine effects of the probiotic Enterococcus faecalis on symptoms of allergic rhinitis in patients. Effects of this probiotic on the immune system have been reported by several studies, but the majority of the previous trials were animal studies. In addition, it is well known that symptoms in allergic rhinitis are prone to exhibit high placebo responses. Moreover, recent studies report that even placebos without deception (open-label placebos) are highly effective in reducing symptoms of allergic rhinitis. Our study design combines both new approaches to assess effects on allergic symptoms in patients. The objective of this study is to compare the effects of a probiotic treatment ( E. faecalis ) with effects seen by open-label placebo, concealed placebo treatment and no treatment control., Methods and Analysis: A total of 120 patients with allergic rhinitis will be randomly assigned to one of four different groups: a double-blind probiotic/placebo group (groups 1 and 2), an open-label placebo group (group 3) and a no-treatment group (group 4) to control for spontaneous variation of symptoms. The primary outcome is the evaluation of allergic symptoms using the Combined Symptoms Medication Score. Furthermore, health-related quality of life is examined (Rhinitis Quality of Life Questionnaire). Secondary outcomes include a visual analogue scale on allergic burden and a second quality of life questionnaire. This report describes the study design of the randomised controlled trial., Ethics and Dissemination: The study design was approved by the ethical committee of the UKT Department of Psychosomatic Medicine and Psychotherapy, Tübingen, Germany. The trial is registered at the German Clinical Trials Register (www.drks.de, DRKS00015804). The trial results will be published in peer-reviewed journals and at conferences., Trial Registration Number: German Clinical Trials Register (www.drks.de, DRKS00015804); Pre-results., Competing Interests: Competing interests: PE is a consultant of PrecisionBiotics, Cork, Ireland, as well as of SymbioPharm, Herborn, Germany (the company that provided the probiotic) and Parexel, Durham, North Carolina, USA, companies that produce probiotics. He has also received travel support from Danone, Paris, France and travel support and speaker honorarium from Biocodex, Paris, France; both companies also produce probiotics., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Accumulating evidence indicates that the gut microbiota communicates with the central nervous system, possibly through neural, endocrine, and immune pathways, and influences brain function. B. longum 1714™ has previously been shown to attenuate cortisol output and stress responses in healthy subjects exposed to an acute stressor. However, the ability of B. longum 1714™ to modulate brain function in humans is unclear., Methods: In a randomized, double-blinded, placebo-controlled trial, the effects of B. longum 1714™ on neural responses to social stress, induced by the "Cyberball game," a standardized social stress paradigm, were studied. Forty healthy volunteers received either B. longum 1714™ or placebo for 4 weeks at a dose of 1 × 10 cfu/d. Brain activity was measured using magnetoencephalography and health status using the 36-item short-form health survey., Results: B. longum 1714™ altered resting-state neural oscillations, with an increase in theta band power in the frontal and cingulate cortex (P < 0.05) and a decrease in beta-3 band in the hippocampus, fusiform, and temporal cortex (P < 0.05), both of which were associated with subjective vitality changes. All groups showed increased social stress after a 4-week intervention without an effect at behavioral level due to small sample numbers. However, only B. longum 1714™ altered neural oscillation after social stress, with increased theta and alpha band power in the frontal and cingulate cortex (P < 0.05) and supramarginal gyrus (P < 0.05)., Discussion: B. longum 1714™ modulated resting neural activity that correlated with enhanced vitality and reduced mental fatigue. Furthermore, B. longum 1714™ modulated neural responses during social stress, which may be involved in the activation of brain coping centers to counter-regulate negative emotions.

Background: Numerous meta-analyses have recently assessed the overall clinical benefit of single therapy options and groups of therapies in the irritable bowel syndrome (IBS). By large, this should enable physicians to select from a number of therapy options available., Methods: We entered dichotomous outcome data from 121 IBS trials published over the last 35 years with different groups and subgroups of drugs (antispasmodics, motility-affecting agents, antidepressants, peppermint oil), dietary interventions (bran, probiotics), and psychotherapy (cognitive behavioral, psychodynamic, hypnotherapy, relaxation techniques) into meta-analytic tools and estimate the overall efficacy (odds ratio, number needed to treat)., Results: Highest efficacy is currently found for peppermint oil, followed by psychotherapeutic and psychopharmacological interventions and probiotics. Traditional antispasmodic therapy has a moderate efficacy, whereas the list of (partially failed or cancelled) motility affecting drugs yielded weak clinical results, and therapies by bran and fibers are of no value in IBS., Conclusion: Evidence-based therapy in IBS provides a number of effective treatment options beyond the fact that many novel compounds under development have failed to reach the market. An algorithm for clinical therapy decision is proposed.

Probiotic bacteria are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. There is a growing interest in probiotics within the scientific community, with consumers, and in the food industry. The interactions between the gut and intestinal microbiota and between resident and transient microbiota define a new arena in physiology, an understanding of which would shed light on the "cross-talk" between humans and microbes. The different beneficial effects of specific probiotic strains may be translated into different health claims. However, there is a need for comprehensive and harmonized guidelines on the assessment of the characteristics and efficacy of probiotics and of foods containing them. An international expert group of ILSI has evaluated the published evidence of the functionality of different probiotics in 4 areas of (human) application: 1) metabolism, 2) chronic intestinal inflammatory and functional disorders, 3) infections, and 4) allergy. Based on the existing evidence, concrete examples of demonstration of benefits and gaps are listed, and guidelines and recommendations are defined that should help design the next generation of probiotic studies.

Ulcerative colitis and Crohn's disease, the 2 distinct idiopathic pathologies of inflammatory bowel diseases, are spontaneously relapsing, immunologically mediated disorders of the gastrointestinal tract. Selected probiotics strains have been proven to be clinically effective in maintaining remission in patients with ulcerative colitis. None of the probiotics thus far tested has been shown to be effective in induction of remission or in maintenance of remission in patients with Crohn's disease. The multispecies probiotics mixture of 8 strains seems effective in the maintenance of remission in pouchitis. Irritable bowel syndrome is a functional bowel disorder manifested by chronic, recurring abdominal pain or discomfort associated with disturbed bowel habit in the absence of structural abnormalities likely to account for these symptoms. Recently conducted appropriately powered studies with different (combinations of) probiotics show positive results on reduction of symptoms, although a considerable placebo effect is also found. Mechanistic studies aimed at pathophysiological mechanisms of inflammatory bowel diseases can identify new targets for probiotic bacteria.

Functional bowel disorders (FBD) resemble a group of diseases of the gastrointestinal (GI) tract that are without a clear pathogenesis; the best known is probably the “irritable bowel syndrome” (IBS). Only recently we have been able to explore the role of the gut microbiota in FBD due to progress in microbiological analytic techniques. There are different ways to explore the role of the gut microbiota and its dysbiosis in FBD. Comparison of the microbial composition in a group of patients with FBD, for example, with IBS to a group of healthy volunteers is one way. Studies have shown that the microbiota in FBD is different from that of healthy controls, but the recorded differences are not necessarily specific for FBD, they may also occur in other diseases. Another approach to explore the role of the gut microbiota in FBD is to challenge the existing “flora” with novel bacteria (probiotics) or with nutritional substrates that stimulate bacterial growth (prebiotics). More than 60 such trials including several thousand patients have been performed in IBS. These studies have produced mixed outcome: some probiotics appear to be better than others, and some appear to work only for a part of the IBS symptoms and not for all. An extreme form of this approach is the transfer of an entire microbiota from 1 healthy person to another, called fecal microbiota transplantation. This has rarely been tested in FBD but is not without risk in benign disorders. [ABSTRACT FROM AUTHOR]

To systematically review the effects of probiotics on central nervous system function in animals and humans, to summarize effective interventions (species of probiotic, dose, duration), and to analyze the possibility of translating preclinical studies. Literature searches were conducted in Pubmed, Medline, Embase, and the Cochrane Library. Only randomized controlled trials were included. In total, 38 studies were included: 25 in animals and 15 in humans (2 studies were conducted in both). Most studies used Bifidobacterium (eg, B. longum, B. breve, and B. infantis) and Lactobacillus (eg, L. helveticus, and L. rhamnosus), with doses between 109 and 1010 colony-forming units for 2 weeks in animals and 4 weeks in humans. These probiotics showed efficacy in improving psychiatric disorder-related behaviors including anxiety, depression, autism spectrum disorder (ASD), obsessive-compulsive disorder, and memory abilities, including spatial and non-spatial memory. Because many of the basic science studies showed some efficacy of probiotics on central nervous system function, this background may guide and promote further preclinical and clinical studies. Translating animal studies to human studies has obvious limitations but also suggests possibilities. Here, we provide several suggestions for the translation of animal studies. More experimental designs with both behavioral and neuroimaging measures in healthy volunteers and patients are needed in the future. [ABSTRACT FROM AUTHOR]

Background/Aims Despite numerous randomized clinical trials and meta-analyses, there is no increased evidence for the efficacy of probiotics in the treatment of irritable bowel syndrome (IBS). We review this evidence, identify and analyse the reasons for this lack of evidence and propose methodological improvements for future studies. Methods Based on a literature search, we identified 56 papers that matched the purpose of our analyses. Twenty-seven studies used multi-species bacterial preparations and 29 used single-strain probiotics. They were analysed regarding patients included, treatment duration, probiotic dosage, and outcome measures. Results Trials in both groups suffered from heterogeneity with respect to probiotic concentration, duration of treatment, and other methodological issues (crossover design and underpowered studies). This heterogeneity did not allow the application of a meta-analytic approach and a systematic review was therefore performed instead. Multi-strain preparations combined 2 to 8 different bacterial subspecies, mostly lactobacilli or bifidobacteria, and used variable lengths of treatments. Overall, more than 50% of trials presented negative outcomes. The majority of the single-strain probiotic trials employing lactobacilli or Saccharomyces were negative, whereas trials employing bifidobacteria showed positive results. Conclusions The heterogeneity of the studies of probiotics in IBS questions the value of meta-analyses. The use of different bacterial strains and different mixtures of these strains, as well as different dosages, are the main contributors to this heterogeneity. Current data provides limited evidence for the efficacy of a small number of single-strain probiotics in IBS (mostly bifidobacteria) and sound studies following strict trial guidelines (Food and Drug Administration and European Medicines Agency guidelines for clinical trials) are needed. We summarised and proposed some methodological issues for future studies in the field. [ABSTRACT FROM AUTHOR]

Sinusitis is a frequent complication of respiratory tract infections. Probiotics are perceived to be useful in infections, allergies, and inflammations. Our prospective trial stratified 204 children with recurrent rhinosinusitis by age (2-11 years, 54m:64f; 12-18 years, 39m:47f) and assigned them to standard treatment (antibiotics, anticongestants) or additional 60 days Symbioflor-1 (SF1; Enterococcus faecalis 1.5-4.5x10 CFU). The number of sinusitis episodes was lower in SF1-treated patients (2.52±0.91) than among controls (3.27±1.36; p=0.01). Mean duration of the first sinusitis episode was 11.9±8.6 days with SF1, whereas it was 16.1±12.9 days in the younger controls (p=0.023) and 9.86±5.05 days in the elder controls (n.s.). Duration of subsequent sinusitis episodes was also shorter in SF1 patients (15.2±13.6 days) compared with controls (22.7±14.8 days; p=0.030). No adverse events were observed. Probiotic Enterococcus faecalis adjuvant to conventional therapy can reduce the number and duration of rhinosinusitis episodes in children and adolescents. [ABSTRACT FROM AUTHOR]

Ulcerative colitis and Crohn's disease, the 2 distinct idiopathic pathologies of inflammatory bowel diseases, are spontaneously relapsing, immunologically mediated disorders of the gastrointestinal tract. Selected probiotics strains have been proven to be clinically effective in maintaining remission in patients with ulcerative colitis. None of the probiotics thus far tested has been shown to be effective in induction of remission or in maintenance of remission in patients with Crohn's disease. The multispecies probiotics mixture of 8 strains seems effective in the maintenance of remission in pouchitis. Irritable bowel syndrome is a functional bowel disorder manifested by chronic, recurring abdominal pain or discomfort associated with disturbed bowel habit in the absence of structural abnormalities likely to account for these symptoms. Recently conducted appropriately powered studies with different (combinations of) probiotics show positive results on reduction of symptoms, although a considerable placebo effect is also found. Mechanistic studies aimed at pathophysiological mechanisms of inflammatory bowel diseases can identify new targets for probiotic bacteria. [ABSTRACT FROM AUTHOR]

Background: Functional gastrointestinal disorders such as irritable bowel syndrome (IBS) report clinical improvement following probiotic therapy, but whether psychiatric comorbidity and quality-of-life in IBS improves directly or in directly is unknown. This meta-analysis synthesized the evidence regarding the effects of probiotics on quality of life (QoL), anxiety and depression in IBS. Methods: The review was executed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines using the databases PubMed, Web of Science and Cochrane Library. For QoL, the data were meta-analyzed, and for anxiety and depression a qualitative analysis was performed. Results: Thirty-five placebo-controlled studies were included of which 11 were eligible for meta-analysis. QoL improved with probiotic and placebo similarly, with the probiotic interventions slightly superior (mean QoL difference—0.36 (95% CI: 0.07, 0.64); p = 0.01). Anxiety and depression were similar between placebo and probiotic groups following therapy. Conclusion: For IBS, probiotic therapy improved QoL, but had no effects on anxiety and depression. However, the applied probiotics were not developed for selective effects on psyche and the brain. Therefore, it remains to be shown whether or not patients with IBS would benefit from second generation probiotics developed for these central effects (psychobiotics). [ABSTRACT FROM AUTHOR]