A preliminary investigation of the safety and effectiveness of oral probiotics supplementation for enhancing vaginal health in females with mild to moderate bacterial vaginosis - An open-label, single-arm, prospective interventional proof-of-science study. - Nil

Start Date28 May 2024

Sponsor / Collaborator-

IRCT20240410061465N2 / RecruitingPhase 1IIT

Investigating the effect of native engineered probiotic supplement on cognitive function and quality of life of Alzheimer's patients

Start Date21 May 2024

Sponsor / Collaborator-

CTRI/2024/05/067236 / Not yet recruitingNot Applicable

A preliminary investigation of the safety and effectiveness of oral probiotics supplementation for reducing the risk of kidney stone in adults with recurrent kidney stone colic or acute episode of colicky pain: An open-label, single-arm, prospective, interventional, proof-of-science study. - Nil

Start Date20 May 2024

Sponsor / Collaborator-

100 Clinical Results associated with Probiotic(Mendes)

100 Translational Medicine associated with Probiotic(Mendes)

100 Patents (Medical) associated with Probiotic(Mendes)

6,560

Literatures (Medical) associated with Probiotic(Mendes)

31 Dec 2024·Gut microbes

Article

Author: Marasco, Giovanni ; Valenza, Alice ; Taverniti, Valentina ; Cremon, Cesare ; De Vitis, Valerio ; Fiore, Walter ; Mantegazza, Giacomo ; Ferrari, Roberto ; Barbara, Giovanni ; Duncan, Robin ; Gargari, Giorgio ; Barbaro, Maria Raffaella ; Guglielmetti, Simone

Probiotics are exploited for adjuvant treatment in IBS, but reliable guidance for selecting the appropriate probiotic to adopt for different forms of IBS is lacking. We aimed to identify markers for recognizing non-constipated (NC) IBS patients that may show significant clinical improvements upon treatment with the probiotic strain Lacticaseibacillus paracasei DG (LDG). To this purpose, we performed a post-hoc analysis of samples collected during a multicenter, double-blind, parallel-group, placebo-controlled trial in which NC-IBS patients were randomized to receive at least 24 billion CFU LDG or placebo capsules b.i.d. for 12 weeks. The primary clinical endpoint was the composite response based on improved abdominal pain and fecal type. The fecal microbiome and serum markers of intestinal (PV1 and zonulin), liver, and kidney functions were investigated. We found that responders (R) in the probiotic arm (25%) differed from non-responders (NR) based on the abundance of 18 bacterial taxa, including the families Coriobacteriaceae, Dorea spp. and Collinsella aerofaciens, which were overrepresented in R patients. These taxa also distinguished R (but not NR) patients from healthy controls. Probiotic intervention significantly reduced the abundance of these bacteria in R, but not in NR. Analogous results emerged for C. aerofaciens from the analysis of data from a previous trial on IBS with the same probiotic. Finally, C. aerofaciens was positively correlated with the plasmalemmal vesicle associated protein-1 (PV-1) and the markers of liver function. In conclusion, LDG is effective on NC-IBS patients with NC-IBS with a greater abundance of potential pathobionts. Among these, C. aerofaciens has emerged as a potential predictor of probiotic efficacy.

01 Dec 2024·Applied microbiology and biotechnology

Therapeutic applications of gut microbes in cardiometabolic diseases: current state and perspectives

Review

Author: Xie, Xinqiang ; Wang, Juan ; Zhao, Hui ; Zhang, Jumei ; Chen, Moutong ; Gu, Qihui ; Yuan, Lin ; Li, Ying ; Ding, Yu ; Xue, Liang ; Wu, Qingping

Abstract:

Cardiometabolic disease (CMD) encompasses a range of diseases such as hypertension, atherosclerosis, heart failure, obesity, and type 2 diabetes. Recent findings about CMD’s interaction with gut microbiota have broadened our understanding of how diet and nutrition drive microbes to influence CMD. However, the translation of basic research into the clinic has not been smooth, and dietary nutrition and probiotic supplementation have yet to show significant evidence of the therapeutic benefits of CMD. In addition, the published reviews do not suggest the core microbiota or metabolite classes that influence CMD, and systematically elucidate the causal relationship between host disease phenotypes-microbiome. The aim of this review is to highlight the complex interaction of the gut microbiota and their metabolites with CMD progression and to further centralize and conceptualize the mechanisms of action between microbial and host disease phenotypes. We also discuss the potential of targeting modulations of gut microbes and metabolites as new targets for prevention and treatment of CMD, including the use of emerging technologies such as fecal microbiota transplantation and nanomedicine.

Key points:

• To highlight the complex interaction of the gut microbiota and their metabolites with CMD progression and to further centralize and conceptualize the mechanisms of action between microbial and host disease phenotypes.• We also discuss the potential of targeting modulations of gut microbes and metabolites as new targets for prevention and treatment of CMD, including the use of emerging technologies such as FMT and nanomedicine.• Our study provides insight into identification-specific microbiomes and metabolites involved in CMD, and microbial-host changes and physiological factors as disease phenotypes develop, which will help to map the microbiome individually and capture pathogenic mechanisms as a whole.

Graphical Abstract:

01 Apr 2024·Tissue & cell

Effects of probiotic supplementation on chronic inflammatory process modulation in colorectal carcinogenesis

Article

Author: Durán, Nelson ; Socca, Eduardo Augusto Rabelo ; de Souza, Bianca Ribeiro ; Reis, Sabrina Karen ; Fávaro, Wagner José ; Genaro, Sandra Cristina

The current study investigated the potential effects of probiotic supplementation on colorectal carcinogenesis chemically induced with 1,2-dimethylhydrazine (DMH) and treated with 5-fluorouracil (5FU)-based chemotherapy in mice. Animals were randomly allocated in five different groups: Control: which not receive any treatment throughout the experimental course; Colitis model group (DMH): treated with DMH; DMH+ 5FU: animals received I.P. (intraperitoneal) dose of chemotherapy on a weekly basis; DMH+PROB: animals received daily administrations (via gavage) of probiotics (Lactobacillus: acidophilus and paracasei, Bifidobacterium lactis and bifidum); and DMH+ PROB+ 5FU: animals received the same treatment as the previous groups. After ten-week treatment, mice's large intestine was collected and subjected to colon length, histopathological, periodic acid-schiff (PAS) staining and immunohistochemistry (TLR2, MyD88, NF-κB, IL-6, TLR4, TRIF, IRF-3, IFN-γ, Ki-67, KRAS, p53, IL-10, and TGF-β) analyzes. Variance (ANOVA) and Kruskal-Wallis tests were used for statistical analysis, at significance level p 0.05. Probiotics' supplementation has increased the production of Ki-67 cell-proliferation marker, reduced body weight, and colon shortening, as well as modulated the chronic inflammatory process in colorectal carcinogenesis by inhibiting NF-κB expression and mitigating mucin depletion. Thus, these findings lay a basis for guide future studies focused on probiotics' action mechanisms in tumor microenvironment which might have implications in clinical practice.

News (Medical) associated with Probiotic(Mendes)

27 Jun 2023

·www.prnewswire.com

With Growing Global Safety Concerns Over Sleep Aids, FitBiomics Co-Authors Study Showcasing New Probiotic Alternative

Nella Study Highlights Significant Improvements in Sleep Quality By 69%; Energy Levels by 31% and Bowel Movements by 37% NEW YORK, June 27, 2023 /PRNewswire/ -- Researchers are unveiling the remarkable effects of Nella, a multi-strain probiotic consortium developed by microbiome innovation company FitBiomics, on promoting sleep quality in humans in a study released today on World Microbiome Day. With a cutting-edge, two-phase clinical approach, the study showcases Nella's broader health benefits along with its potential to transform the way we approach sleep and probiotic alternatives to sleep aids. "In the context of rising sleep disorder diagnoses impacting over 50 million people in the U.S., especially during the pandemic, our research introduces compelling findings on the role of probiotics in health and wellbeing," explains Alex Kostic, PhD the study's corresponding author, FitBiomic Co-Founder and Asst. Professor of Microbiology at Harvard Medical School. "Our study indicates that the probiotic consortium in Nella significantly enhances sleep quality which is noteworthy given the growing concerns around the use of traditional sleep aids." The research, which initially observed improvements in sleep quality in a diverse group of individuals, has now been validated through a rigorous placebo-controlled study involving the following: The study, split into two parts, evaluated the effects of a FitBiomics proprietary multi-strain Lactobacillus probiotic on safety as well as a comprehensive list of health outcomes. The first part of the study, an open label trial, involved 257 participants from the general public (average age 40.9 years old) who took 1 capsule of probiotic (either a high or low dose) daily for 2 weeks. 94% of participants reported notable health improvements after completing this regimen , particularly in sleep quality and energy. The second part of the study, a placebo-controlled trial, involved 11 professional soccer players. Significant improvements in sleep quality (69%), energy levels (31%), and bowel regularity (37%) were observed in the probiotic group compared to the placebo group. Therefore, the improvements in sleep and energy first identified in the open label trial were independently validated in the placebo-controlled trial. Nella's probiotic consortium offers a safe and potentially more consistent solution to sleep-related issues compared to current sleep aids. Beyond its impact on sleep quality, the study revealed significant enhancements in energy levels and bowel movements, demonstrating the probiotic's multifaceted benefits across various populations. The research notably suggests a link between the observed health improvements and decreased levels of oxidative stress in the body, the latter being a condition that can lead to cell and tissue damage over time. Additionally, there was an increased ratio between free-testosterone and cortisol, which is associated with improved recovery from physical exertion and could explain the increased energy of the participants. Extensive blood and stool analyses from the study demonstrated significant reductions in oxidative stress and inflammation, offering a potential explanation of how the probiotic enhances sleep. Furthermore, multi-omics analysis of stool samples illuminated a biological pathway that leads to increased antioxidant production by gut microbes, supporting the body's response to sleep deprivation. The research proposes an innovative model of how this probiotic consortium influences host physiology and stress response, potentially enhancing sleep quality, exercise recovery, and overall health. The health benefits of this probiotic intervention are hypothesized to center around oxidative stress regulation, hormonal modulation, and immune responses, with particular gut microbes identified as playing crucial roles. "This study marks an important milestone in our understanding of the role probiotics play in improving sleep quality and overall health. As the global population increasingly turns to probiotics for a range of health benefits, these findings pave the way for advanced probiotic interventions that can revolutionize wellness," remarks Neuroscientist & Sleep Researcher and FitBiomics advisor Allison Brager, PhD. "Nella has not only been shown to improve sleep quality but also next day performance and energy levels. Again, another piece of evidence that Nella facilitates efficient energy utilization." The team behind this research has a history of notable discoveries, including previous work published in prestigious journals such as Nature Medicine and featured in respected media outlets like The New York Times, Scientific American, and NPR's Science Friday. Their ongoing efforts continue to shed light on the intricate and vital role the gut microbiome plays in human health and performance. "What better time than World Microbiome Day to recognize fresh insights into the molecular mechanisms driving these health benefits," says Jonathan Scheiman, PhD, CEO and co-founder of Fitbiomics. "This research highlights the specific changes in gut microbiome composition and function that contribute to Nella's effectiveness and also underscores our ability to translate microbiome research into real world health solutions that have the potential to benefit broad populations." In addition, the FitBiomics research team will be releasing another study on its newest product Veillonella in the next few months to coincide with when the product is available for consumer purchases. For more information on the Nella study and its findings, please contact: [email protected]. About FitBiomics FitBiomics is enhancing human health & wellness by decoding the microbiome of the most fit and healthy people in the world, then translating that biological information into next-generation nutrition. Dedicated to promoting health equity by making microbiome innovations accessible to everybody, FitBiomics is developing a platform of microbiome solutions to support health and longevity. The company's first product is Nella, a daily probiotic supplement designed to support better digestion, sleep, and energy, with more products to come from their innovation platform. For more information visit: SOURCE FitBiomics

Microbial therapyClinical Study

17 Jan 2023

·www.sciencedaily.com

Probiotic markedly reduces S. Aureus colonization in phase 2 trial

A promising approach to control Staphylococcus aureus bacterial colonization in people -- using a probiotic instead of antibiotics -- was safe and highly effective in a Phase 2 clinical trial. The new study found that the probiotic Bacillus subtilis markedly reduced S. aureus colonization in trial participants without harming the gut microbiota, which includes bacteria that can benefit people. A promising approach to control Staphylococcus aureus bacterial colonization in people -- using a probiotic instead of antibiotics -- was safe and highly effective in a Phase 2 clinical trial. The new study, reported in The Lancet Microbe, found that the probiotic Bacillus subtilis markedly reduced S. aureus colonization in trial participants without harming the gut microbiota, which includes bacteria that can benefit people. The research was conducted by researchers at the National Institutes of Health led by Michael Otto, Ph.D., an NIH senior investigator at the National Institute of Allergy and Infectious Diseases (NIAID). Methicillin-resistant S. aureus, or MRSA, is familiar to many people as a cause of serious disease. Less well known is that S. aureus often lives in the nose, on the body and in the gut without causing any harm. However, if the skin barrier is broken, or the immune system compromised, these colonizing bacteria can cause serious skin, bone, lung, and blood infections. The prevention of S. aureus infections using approaches to "decolonize" the body has gained increased attention as the spread of antibiotic resistance limits treatment options. Some decolonization strategies are controversial because they also require large amounts of antibiotics, raising concerns about damage to the microbiota and the development of antibiotic resistance. So far, it appears that only nasal S. aureus colonization can be targeted with topical antibiotics without doing too much harm, but bacteria quickly can recolonize in the nose from the gut. Probiotics, digestive supplements containing live microorganisms, may be a way to complement or replace antibiotics. Probiotic Bacillus is especially promising because it is administered orally as spores that can survive passage through the stomach and then temporarily grow in the intestine. In prior studies, Dr. Otto's group discovered an S. aureus sensing system needed for S. aureus to grow in the gut. They also found that fengycins, Bacillus lipopeptides that are part peptide and part lipid, prevent the S. aureus sensing system from functioning, thereby eliminating the bacteria. In the clinical trial, conducted in Thailand, the research team tested whether this approach works in people. They enrolled 115 healthy participants, all of whom were colonized naturally with S. aureus. A group of 55 people received B. subtilis probiotic once daily for four weeks; a control group of 60 people received a placebo. After four weeks researchers evaluated the participants' S. aureus levels in the gut and nose. They found no changes in the control group, but in the probiotic group they observed a 96.8% S. aureus reduction in the stool and a 65.4% reduction in the nose. "The probiotic we use does not 'kill' S. aureus, but it specifically and strongly diminishes its capacity to colonize," Dr. Otto said. "We think we can target the 'bad' S. aureus while leaving the composition of the microbiota intact." The researchers also found that levels of S. aureus bacteria in the gut far exceeded S. aureus in the nose, which for decades has been the focus of staph infection prevention research. This finding adds to the potential importance of S. aureus reduction in the gut. "Intestinal S. aureus colonization has been evident for decades, but mostly neglected by researchers because it was not a viable target for antibiotics," Dr. Otto said. "Our results suggest a way to safely and effectively reduce the total number of colonizing S. aureus and also call for a categorical rethinking of what we learned in textbooks about S. aureus colonization of the human body." The researchers plan to continue their work by testing the probiotic in a larger and longer trial. They note that their approach probably does not work as quickly as antibiotics, but can be used for long periods because the probiotic as used in the clinical trial does not cause harm. Study collaborators in Thailand are from Rajamangala University of Technology Srivijaya, and Prince of Songkla University.

Clinical ResultPhase 2

09 Jun 2022

·www.sciencedaily.com

'Good' bacteria to tackle depression

Intestinal flora plays an important role in health -- including mental health. Researchers have shown that probiotics can support the effect of antidepressants and help to alleviate depression. Intestinal flora plays an important role in health -- including mental health. Researchers from the University of Basel and the University Psychiatric Clinics Basel (UPK) have shown that probiotics can support the effect of antidepressants and help to alleviate depression. When he was visited by what he called "the black dog," Winston Churchill could barely get out of bed. He had no energy, no interests and no appetite. Although the British prime minister didn't invent this metaphor for depression, he was the one who popularized it. Experts use medication and psychotherapy to try to help patients escape from the "black dog," but it persists in some individuals. Researchers are therefore searching for ways to improve existing therapies and develop new ones. One promising approach is the microbiome-gut-brain axis. The microbiome is generally understood to mean all the microorganisms that live in or on the human body, such as the intestinal flora. Intestinal bacteria can influence the nervous system for instance via metabolic products. In a recent study, a research team from the University of Basel and the University Psychiatric Clinics Basel (UPK) has shown that probiotics can support treatment with antidepressants. They have reported their findings in the journal Translational Psychiatry. Intestinal flora influences the psyche It is known from previous studies that patients with depression show an above-average prevalence of intestinal and digestive problems. If the intestinal flora of people with depression is implanted in mice raised in sterile conditions -- that is, with no intestinal flora -- then the animals also develop depressive-like behavior. For example, they are less energetic and show decreased interest in their surroundings than their peers. Researchers therefore suspect that the composition of the bacterial community in the gut plays an important role in depressive symptoms. In their new study, the researchers led by Dr. André Schmidt and Professor Undine Lang systematically investigated the effects of probiotics on patients with depression. All participants were inpatients at the University Psychiatric Clinics Basel (UPK) and were given a probiotic (21 subjects) or a placebo (26 subjects) for 31 days, in addition to antidepressants. Neither the participants nor the study staff knew which preparation the subjects were taking throughout the study period. The researchers carried out a series of tests on the participants immediately before treatment, at the end of the 31 days and again four weeks later. The subsequent analysis showed that although depressive symptoms decreased in all participants thanks to the general antidepressant treatment, there was a greater improvement in the subjects in the probiotic group than in the placebo group. In addition, the composition of their intestinal flora changed, at least temporarily: in the probiotic group, an analysis of stool samples revealed an increase in lactic acid bacteria at the end of treatment -- an effect that was accompanied by a reduction in depressive symptoms. However, the level of these health-promoting gut bacteria decreased again over the following four weeks. "It may be that four weeks of treatment is not long enough and that it takes longer for the new composition of the intestinal flora to stabilize," explains Anna-Chiara Schaub, one of the lead authors of the study. Change in the processing of emotional stimuli Another interesting effect of taking probiotics was seen in relation to brain activity when viewing neutral or fearful faces. The researchers investigated this effect using functional magnetic resonance imaging (fMRI). In patients with depression, certain brain regions for emotional processing behave differently than in individuals with good mental health. After four weeks of probiotics, this brain activity normalized in the probiotic group but not in the placebo group. "Although the microbiome-gut-brain axis has been the subject of research for a number of years, the exact mechanisms are yet to be fully clarified," says Schaub. This was another reason why the researchers believed it was important to use a wide range of bacteria in the form of probiotics, such as formulations already available on the market. "With additional knowledge of the specific effect of certain bacteria, it may be possible to optimize the selection of bacteria and to use the best mix in order to support treatment for depression," says the researcher -- although she is keen to emphasize that probiotics are not suitable as a sole treatment for depression.

100 Deals associated with Probiotic(Mendes)

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESPE2023	Not Applicable	Diabetes Mellitus, Type 1	-	probiotic	daoiavwbnu(ntaaqwfruj) = ecqtpfplee nkyfmkwnwj (igvnwtrkil ) View more	Positive	21 Sep 2023
IRCT2017082434497N4 (Pubmed \| Clin Nutr)	Phase 2	Parkinson Disease	-	Probiotic	gjukrgeaav(kcmjkwlxoj) = purbxntmwb vlbkwgmxrk (bcioizcvvc ) View more	-	01 Jun 2019
				probiotic (Placebo)	gjukrgeaav(kcmjkwlxoj) = lanmnriauq vlbkwgmxrk (bcioizcvvc ) View more
Pubmed \| Diabetes Care	Not Applicable	Overweight \| Obesity	439	Fish oil + placebo	pbwwwmtppt(awzzjqnwlm) = abwjjtkuyb jwqpfqrafz (vnjpaziohm )	-	01 Jun 2019
				Fish oil + probiotics	pbwwwmtppt(awzzjqnwlm) = izkirsqxap jwqpfqrafz (vnjpaziohm )
CTRI/2009/091/001042 (ESMO2018)	Phase 2/3	Diarrhea \| Neoplasms	291	High potency multistrain probiotic	vevcfbepjl(nvgjjickwz) = paognsdkyq zoxgorfpkq (hrnjtqenbt ) View more	-	21 Oct 2018
				Placebo	vevcfbepjl(nvgjjickwz) = wxfavhkfuh zoxgorfpkq (hrnjtqenbt ) View more
NCT02011542 (CTgov)	Phase 2/3	-	29	VSL	mcuphvwmtr(ksibwlwhwj) = izgbjafdsc ffiptrwhrk (eytqpfmctc, khlmhsgdlo - yzslptamdv) View more	-	16 Jan 2018
Pubmed \| Pediatrics	Not Applicable	Eczema \| Asthma	-	Lactobacillus rhamnosus GG (LGG) supplementation	hwacmcofmz(saiayphnxa) = uuwtikmclw zpeztwjaie (dpmksqpsns, 19.4% - 38.0%) View more	Negative	01 Sep 2017
				Probiotic	hwacmcofmz(saiayphnxa) = bkrlofqtos zpeztwjaie (dpmksqpsns, 21.4% - 40.4%) View more
Pubmed \| Nutrition	Not Applicable	Depressive Disorder, Major	40	Probiotic supplements	gxulhipkia(ooryablymf) = fgatwwjnmr hfqcrlrogc (hjrbnjiutv ) View more	Positive	01 Mar 2016
				Placebo	gxulhipkia(ooryablymf) = pccrejubkc hfqcrlrogc (hjrbnjiutv ) View more
NHANES (ASN2015)	Not Applicable	Albuminuria	6,853	Probiotic	rgjodsteqc(uetwhjxbfc) = vhnyyreley vvgpwfvgpr (machfvtkvs ) View more	Positive	03 Nov 2015
				Probiotic	-
ASN2015	Not Applicable	Acute Tubulointerstitial Nephritis	-	Probiotic Lactobacillus GG	lltkforvpe(fddghzesvq) = The biopsy revealed patchy tubular atrophy and interstitial fibrosis affecting 10% of the cortical area with a few mononuclear inflammatory cells and focal mild lymphocytic tubulitis, consistent with resolving AIN seujnaoais (bmpmnpfdwh )	Negative	03 Nov 2015
ERS2015	Not Applicable	-	185	Lactobacillus GG (LGG) supplementation	nkgutjamzd(ddjsaysjtg) = ihlgyiwikd dmllejpery (gghbzjineb ) View more	Negative	01 Sep 2015
				probiotic	nkgutjamzd(ddjsaysjtg) = logszjfguj dmllejpery (gghbzjineb ) View more

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