Safety Of Probiotics Research Articles

Genome sequence and evaluation of safety and probiotic potential of Lacticaseibacillus paracasei LC86 and Lacticaseibacillus casei LC89

AimA comprehensive safety assessment of potential probiotic strains was essential for their application in the food industry. This article systematically evaluated the probiotic characteristics, whole-genome sequence analysis and safety of Lacticaseibacillus paracasei LC86 and Lacticaseibacillus casei LC89.MethodsFirstly, the two strains of lactic acid bacteria selected were identified. Secondly, whole-genome sequencing was performed on LC86 and LC89, and their antibiotic resistance, pathogenicity, and virulence genes were analyzed. We tested various properties of the two strains, included tolerance, cell adhesion, hemolytic activity, catalase activity, gelatin hydrolysis, arginine hydrolysis ability, bile salt hydrolysis capacity, mucin degradation, bioamine, D-/L-lactic acid production and antibiotic susceptibility, to confirm the safety of LC86 and LC89 both in vitro and in vivo. Additionally, we studied the acute toxicity of LC86 and LC89 in mice through a 14-day oral gavage experiment.ResultsThe two strains selected were identified as Lacticaseibacillus paracasei and Lacticaseibacillus casei. The genomes of both LC86 and LC89 were devoid of virulence, antibiotic resistance and pathogenicity genes. LC86 and LC89 exhibited good tolerance to temperature, artificial gastric fluid and artificial intestinal fluid; they were non-hemolytic, their catalase activity, gelatin hydrolysis, arginine hydrolysis and bile salt hydrolysis were all negative. They exhibited the capability to break down proteins and demonstrated sensitivity to a range of antibiotics. The oral LD50 for both LC86 and LC89 in mice was >2 × 1010 CFU/kg.ConclusionThe experimental results above demonstrated the probiotic characteristics and safety of LC86 and LC89, indicating their potential as candidates for probiotics for human and animal applications.

Multifunctional probiotic and safety attributes Heyndrickxia coagulans isolated from stingless bee honey

BackgroundHeyndrickxia coagulans, recognized for its probiotic attributes and resilience as an endospore-forming bacterium, is increasingly studied for health supplement applications. This study aimed to evaluate the probiotic potential and safety of novel H. coagulans isolated from stingless bee honey, a new source for this bacterium, and to characterize their multifunctional probiotic properties.ResultsWe isolated two novel H. coagulans, TBRC-18260 and TBRC-18261, and conducted comprehensive in vitro analyses to assess their probiotic traits such as acid and bile salt tolerance, self-aggregation, and pathogen inhibition. Both isolates were also evaluated for safety through antibiotic susceptibility testing and hemolytic activity. Functional properties, including GABA production, antioxidant activity, were examined to establish their potential as probiotics. TBRC-18260 and TBRC-18261 exhibited core probiotic characteristics and showed excellent survivability under acidic conditions and in the presence of bile salts. They displayed strong antimicrobial activity against various pathogens and demonstrated significant GABA production and antioxidant capabilities. The safety assessments confirmed their non-hemolytic nature and susceptibility to a wide range of antibiotics.ConclusionThe novel H. coagulans isolates, TBRC-18260 and TBRC-18261, with their robust probiotic properties, antioxidant activities, and safety profiles, emerged as promising candidates for the development of functional foods and dietary supplements. This study enhances the biodiversity of available probiotics and supports the continuous search for novel strains with unique health-promoting characteristics.

Probiotic Potential, Safety Aspects, and Application of Pediococcus pentosaceusP107 in Food Matrix

Probiotic Potential, Safety Aspects, and Application of <i>Pediococcus pentosaceus</i><scp>P107</scp> in Food Matrix

Probiotics Combined With Trimebutine for the Treatment of Irritable Bowel Syndrome Patients: A Systematic Review and Meta-Analysis.

This study aimed to assess the efficacy and safety of probiotics combined with trimebutine in the treatment of irritable bowel syndrome (IBS), addressing an important gap in current treatment strategies. Randomized controlled trials (RCTs) of trimebutine combined with probiotics for the treatment of IBS were collected from various databases. All retrieved articles were screened and assessed for quality. The methodological quality of the included studies was assessed following the guidelines recommended by the Cochrane Collaboration. The meta-analysis of the included studies was conducted using RevMan 5.3 software. A total of 37 RCTs involving 4360 participants were included in this study. Among them, the treatment group consisted of 2177 participants, and the control group consisted of 2183 participants. The results showed that the overall efficacy of trimebutine combined with probiotics in the treatment of IBS was significantly higher than that of trimebutine alone (odds ratio [OR] = 5.09, 95 % confidence interval [CI] [4.19, 6.20], p < 0.00001). The effective rate in the combination therapy group was 93.5 % compared with 73.8 % in the trimebutine alone group. The safety profile was favorable, with adverse event rates of 1.75 % and 1.69 % in the combination and monotherapy groups, respectively. The most common adverse events were mild and included dry mouth, nausea and dizziness. No serious adverse events were reported in either group. Subgroup analysis based on the type of probiotic intervention showed that combination use was better than trimebutine alone, and the differences between each subgroup were statistically significant. Combination use of compound Lactobacillus capsules had the best effect (OR = 16.03, 95 % CI [4.57, 56.21], p < 0.0001]. These results highlight the potential role of strain-specific benefits in IBS treatment and suggest that probiotic strain selection may significantly influence treatment outcomes. The combination of trimebutine and probiotics is more effective in the treatment of IBS compared with trimebutine alone. https://www.crd.york.ac.uk/prospero/, identifier: CRD42024516044.

Feasibility, safety and tolerability of estrogen and/or probiotics for improving vaginal health in Canadian African, Caribbean, and Black women: A pilot phase 1 clinical trial.

A dysbiotic vaginal microbiome (VMB) is associated with clinical conditions such as bacterial vaginosis (BV) and an increased risk of human immunodeficiency virus (HIV-1) infection. Considering the high prevalence of BV among African, Caribbean and Black (ACB) women, we conducted a prospective, randomized, open-label phase 1 clinical trial to determine the feasibility, safety and tolerability of administering low-dose estrogen, probiotics or both in combination to improve vaginal health and decrease HIV-1 susceptibility. ACB women aged 18-49 from the Greater Toronto Area (GTA) were randomized to one of four study arms: intravaginal estradiol (Estring©; 7.5mg/day); a vaginal probiotic (RepHresh™ Pro-B™) administered twice daily; a combination of Estring© and vaginal RepHresh™ Pro-B™ (twice daily); or the Estring© and oral RepHresh™ Pro-B™ (twice daily), for a duration of 30 days. Feasibility was evaluated through enrolment, retention, and adherence rates, while safety and tolerability were determined by a pre- and post-treatment blood panel and reported adverse events (AEs). Overall, 63 ACB women were screened, 50 were enrolled and received the intervention while 41 completed the study, resulting in 80% enrollment and 82% retention rates. Overall adherence to the study protocol was high at 93%, with an adherence of 92% for RepHresh™ Pro-B™ and 97% for Estring©. A total of 88 AEs were reported by 29 participants which were mild (66/88; 75%) and largely resolved (82/88;93%) by the end of the study, with no serious AEs (SAEs) noted. In addition, a panel of safety blood markers measured pre- and post-intervention confirmed no clinically significant changes in blood chemistry or blood cell count. Overall, the administration of intravaginal estrogen and/or probiotics in pre-menopausal ACB women is feasible, safe, and well tolerated. The trial was registered with Clinicaltrials.gov (NCT03837015) and CIHR HIV Clinical Trials (CTN308).

Genomic Characterization of Probiotic Purple Nonsulfur Bacteria Cereibacter sphaeroides Strains S3W10 and SS15: Implications for Enhanced Shrimp Aquaculture.

Cereibacter sphaeroides strains S3W10 and SS15, isolated from shrimp ponds, exhibit potential probiotic benefits for aquaculture. In this study, the genomic features of S3W10 and SS15 were thoroughly characterized to evaluate their probiotic properties and safety for aquaculture use. The genomes of S3W10 and SS15 consist of 130 and 74 contigs, with sizes of 4.6 Mb and 4.4 Mb and GC contents of 69.2%. Average nucleotide identity (ANI), digital DNA-DNA hybridization (dDDH), and phylogenomic analyses confirmed that these strains belong to C. sphaeroides. Genome annotation predicted 4260 coding sequences (CDS) in S3W10 and 4086 CDS in SS15, including genes associated with stress tolerance, nutrient absorption, and antioxidant activity. Notably, genes related to vitamin B12 synthesis, digestive enzyme production, and carotenoid biosynthesis, which support shrimp health, were identified in both genomes. CAZyme analysis identified 116 and 115 carbohydrate-active enzymes in S3W10 and SS15, respectively, supporting adaptation to gastrointestinal environments and the host immune response. Pan-genome analysis across C. sphaeroides strains revealed 7918 gene clusters, highlighting the open pan-genome structure of this species and its high genetic diversity. Further bioinformatic analyses assessing mobile genetic elements, antibiotic-resistance genes, and virulence factors demonstrated the safety of both strains for aquaculture, as no plasmids or virulence genes were identified. The genomic insights in this study provide a deeper understanding of the strains' adaptability and functional potential, aligning with previous in vitro and in vivo studies and highlighting their potential for use in shrimp cultivation.

Efficacy and Safety of Probiotics as Adjunctive Therapy in Cancer Treatment: A Comprehensive Systematic Review and Meta-Analysis.

The gut microbiome is crucial in influencing cancer progression and response to treatment. We evaluate the efficacy and safety of probiotics and synbiotics in cancer treatment, focusing on the incidence of diarrhea, significant complications, surgical site infections, length of hospital stay, progression-free survival (PFS), and overall survival (OS). Following PRISMA guidelines, a comprehensive literature search was conducted in PubMed, Scopus, Web of Science, and Cochrane CENTRAL up to June 2024. The risk of bias was assessed using the Cochrane Risk-of-Bias tool. Meta-analysis was performed using a random-effects model. Fifteen studies involving 2197 participants were included. Probiotic use was associated with a significant reduction in the incidence of diarrhea (OR=0.39, 95% CI: 0.15-1.00, P=0.049) with moderate heterogeneity (I2=64%). No significant differences were found in major complications (OR=0.50, 95% CI: 0.05-4.92, P=0.4053, I2=73%), surgical site infections (OR=0.36, 95% CI: 0.12-1.09, P=0.058, I2=0%), length of hospital stay (SMD=-0.30, 95% CI: -1.00 to 0.41, P=0.2726, I2=62%), PFS (HR=0.61, 95% CI: 0.03-10.82, P=0.2715, I2=0%), or OS (HR=0.52, 95% CI: 0.00-58.82, P=0.3298, I2=0%). Probiotics significantly reduced the incidence of chemotherapy-induced diarrhea, highlighting their potential as supportive care agents in oncology. However, their impact on significant complications, surgical site infections, length of hospital stay, and survival outcomes remains inconclusive.

Innovative strategies for the rapid restoration of intestinal function in patients undergoing abdominal surgery: use of probiotics. Pilot study of 15 patients.

The clinical value of probiotics in patients undergoing abdominal surgery, particularly colorectal surgery, remains uncertain despite their well-documented health benefits. This pilot randomized controlled trial aimed to assess the effects of perioperative and postoperative oral administration of two probiotics, Clostridium butyricum CBM588® and Bifidobacterium longum ES1, on immune function, systemic inflammatory response, postoperative infections, and recovery after colorectal surgery. Fifteen adult patients underwent colorectal resection, with two groups receiving probiotics and one acting as a control. Blood and fecal samples were collected, and clinical parameters were assessed. Results showed the safety of probiotics, resistance to antibiotics and gastric acid, and potential benefits in reducing postoperative infections and intestinal inflammation. Future trials should provide more conclusive evidence on the efficacy and safety of perioperative probiotic administration in colorectal surgery, aiming for improved patient outcomes and reduced healthcare costs.

Beneficial and Safety Properties of a Bacteriocinogenic and Putative Probiotic Latilactobacillus sakei subsp. sakei 2a Strain.

This work aimed to evaluate some of the probiotic features and safety of the bacteriocin-producing Latilactobacillus sakei subsp. sakei 2a. The effect of selected commercial drugs from different generic groups and antibiotics on the growth of Ltb. sakei subsp. sakei 2a was also determined. The presence of virulence factors was determined based on PCR with total DNA from Ltb. sakei subsp. sakei 2a. Good growth of Ltb. sakei subsp. sakei 2a was recorded in MRS broth supplemented with 0.2% or 0.4% oxbile or in MRS broth adjusted to a pH from 5.0-9.0. Auto-aggregation of Ltb. sakei subsp. sakei 2a was 62.59%. Different levels of co-aggregation were recorded between Ltb. sakei subsp. sakei 2a and Enterococcus faecalis ATCC19443, Ltb. sakei ATCC15521 and Listeria monocytogenes ScottA. Growth of Ltb. sakei subsp. sakei 2a was not inhibited by commercial drugs from different generic groups. The inhibitory effect on the growth of Ltb. sakei subsp. sakei 2a was recorded only in the presence of Arotin [selective serotonin reuptake inhibitor antidepressant] Minimal Inhibition Concentration (MIC) 1.0 mg/mL, Atlansil [Antiarrhythmic] MIC 0.625 mg/mL, Diclofenac potassium [non-steroidal anti-inflammatory drug (NSAID)] MIC 2.5 mg/mL and Spidufen [NSAID] MIC 15.0 mg/mL. Only two antibiotics tested in this study, Amoxil and Urotrobel, inhibited the growth of Ltb. sakei subsp. sakei 2a with a MIC of <0.5 mg/mL and 5.0 mg/mL, respectively. However, Ltb. sakei subsp. sakei 2a generated positive PCR results on the DNA level for vanA (vancomycin resistance), hyl (hyaluronidase), esp (enterococcal surface protein), ace (adhesion of collagen) and cilA (cytolisin) and a high virulence profile when examined for the presence of virulence factors. It is important to underline that cytolysis has been described as a virulence and antibacterial factor.

Functional and molecular characterization of millet associated probiotic bacteria

The lactic acid bacteria are one of the sustainable ways of food production. As the native lactic acid bacteria (LAB) easily manipulate the substrate, helps in production of health essential probiotics with enhancing the bioavailability of the substrate. Here also, in present study, the native LAB isolates isolated from the millets and characterize them for the functional analysis for the human health association. In the present study, fermented millet-associated lactic acid bacteria were screened and characterized for their probiotic potential, safety evaluation and antimicrobial activity. A total of 33 isolates were purified as lactic acid bacteria based on colony shape and biochemical assays. However, only 13 isolates were found to be catalase-negative. Among the 13 isolates, 5 isolates exhibited optimum growth at 6.5% and 9.5% of salt concentrations, pH of 4.5 to 8.5 and 17 °C to 40 °C of the temperature. The probiotic properties of the five isolates exhibited that the survival rates in acid and bile salt concentration ranged from 56.2 to 73.7% and 55.3 to 70.3%, respectively. Similarly, the surface hydrophobicity of the isolates was 41–75%. Antibiotic assay revealed that all five isolates were resistant to Amoxicillin, Cloxacillin, and Penicillin-V. Interestingly, all the isolates except ME26 displayed susceptibility towards Penicillin (2 units) and Tetracycline (10 µg). Further, the four isolates (ME25, ME26, ME9, and ME2) had more antifungal activity against Aspergillus flavus. However, only three, except ME1 and ME2, showed maximum antibacterial activity and produced more antimicrobial compounds compared to reference strain L. plantarum Pb3. The potential probiotic isolates were identified as Weisella cibaria ME9, Weisella cibaria ME26, and Weisella confusa ME25.

Untargeted metabolomics and PacBio analysis on bioactive components and microbial community in co-fermentation of black soldier fly larva

Fermentation can enhance nutritional value and safety of insect protein, this study utilized probiotic Bacillus subtilis (B. subtilis) and complex enzyme containing chitinase and protease to ferment the paste of Black Soldier Fly larva (BSFL), decomposing anti-nutritional factor chitin and protein in paste while inhibiting the proliferation of harmful microorganisms. The result indicated a 40 % degradation of chitin after fermentation, accompanied by an increase in the variety and quantity of amino acids and peptides, functional substances such as raffinose and cucurbitacin significantly increased, while the levels of antibiotics such as erythromycin and ofloxacin had decreased; after fermentation, there is a significant difference in the microbial distribution between bacteria, co-fermentation and CK, the indigenous microbiota of BSF and pathogenic bacteria such as Klebsiella pneumoniae and Clostridiaceae bacteria were significantly inhibited, anaerobic bacteria, including Anaerosalibacter, Caldicoprobacter and Tissierella, exhibit a marked increase; significant changes are detected in the carbon sources, amino acids, and key enzymes related to other metabolic pathways of B. subtilis during the fermentation process. Overall, we have developed a method for fermenting BSFL paste, aiming at enhance its probiotic properties, nutritional value, and safety. This study provided groundwork for utilizing fermented insects as a novel protein source for food and fodder.

A Randomized Double-Blind Placebo-Controlled Study on the Safety and Efficacy of Probiotics for Insulin Resistance and Oxidative Stress Markers in Diabetic Patients With End-Stage Renal Disease on Hemodialysis.

Chronic kidney disease (CKD) is a progressive loss of kidney function that can lead to end-stage renal disease (ESRD), requiring renal replacement therapy. Patients on chronic hemodialysis are at a higher risk of developing cardiovascular disease. This study aimed to investigate the effect of 12-week probiotic supplementation on insulin resistance, oxidative stress, and lipid profiles in diabetic patients with ESRD undergoing hemodialysis. This is a prospective, randomized, parallel-group, double-blind, placebo-controlled study with efficacy parameters including changes in insulin resistance assessed by homeostatic model assessment for insulin resistance (HOMA-IR); oxidative stress markers malondialdehyde (MDA), nitric oxide (NO), and glutathione (GSH); glycemic control (fasting blood sugar (FBS), glycosylated hemoglobin); and lipid profile over 12 weeks of probiotic supplementation in diabetic patients with ESRD on hemodialysis compared to placebo. The study included a total of 47 subjects, 30 men and 17 women with a mean age of 52.68 years, and observed a significant reduction in HOMA-IR with a mean difference of 0.66; improvements in MDA, NO, and GSH with mean differences of 0.92, 6.16, and 24.37 µmol/L, respectively; and a significant improvement in FBS and hemoglobin A1c (HbA1c). Minor self-limiting gastrointestinal adverse events like bloating and constipation were associated with probiotics. Probiotic supplementation can improve insulin resistance in patients with diabetes and ESRD undergoing regular hemodialysis. However, further research is needed to explore its effects on clinical outcomes.

Genomic Characterization of Lactiplantibacillus plantarum Strains: Potential Probiotics from Ethiopian Traditional Fermented Cottage Cheese.

Lactiplantibacillus plantarum is a species found in a wide range of ecological niches, including vegetables and dairy products, and it may occur naturally in the human gastrointestinal tract. The precise mechanisms underlying the beneficial properties of these microbes to their host remain obscure. Although Lactic acid bacteria are generally regarded as safe, there are rare cases of the emergence of infections and antibiotic resistance by certain probiotics. An in silico whole genome sequence analysis of putative probiotic bacteria was set up to identify strains, predict desirable functional properties, and identify potentially detrimental antibiotic resistance and virulence genes. We characterized the genomes of three L. plantarum strains (54B, 54C, and 55A) isolated from Ethiopian traditional cottage cheese. Whole-genome sequencing was performed using Illumina MiSeq sequencing. The completeness and quality of the genome of L. plantarum strains were assessed through CheckM. Analyses results showed that L. plantarum 54B and 54C are closely related but different strains. The genomes studied did not harbor resistance and virulence factors. They had five classes of carbohydrate-active enzymes with several important functions. Cyclic lactone autoinducer, terpenes, Type III polyketide synthases, ribosomally synthesized and post-translationally modified peptides-like gene clusters, sactipeptides, and all genes required for riboflavin biosynthesis were identified, evidencing their promising probiotic properties. Six bacteriocin-like structures encoding genes were found in the genome of L. plantarum 55A. The lack of resistome and virulome and their previous functional capabilities suggest the potential applicability of these strains in food industries as bio-preservatives and in the prevention and/or treatment of infectious diseases. The results also provide insights into the probiotic potential and safety of these three strains and indicate avenues for further mechanistic studies using these isolates.

Pharmacists' Knowledge, Perception, and Prescribing Practice of Probiotics in the UAE: A Cross-Sectional Study.

The human body is a complex and interconnected system where trillions of microorganisms, collectively known as the gut microbiota, coexist with these cells. Besides maintaining digestive health, this relationship also impacts well-being, including immune function, metabolism, and mental health. As frontline healthcare providers, pharmacists are pivotal in promoting the benefits of probiotics for immune support. This study explored pharmacists' knowledge, perception, and practice behavior in the UAE towards the implication of probiotic application beyond digestive health, such as cardiovascular and mental health impacts and their diverse dosage forms. An online self-administered survey was distributed among pharmacists in the UAE. Data were collected through personal visits to pharmacies, where pharmacists were approached and asked to complete the questionnaire. The sample size included 407 pharmacists, determined using the formula for proportions with a 95% confidence level and a 5% margin of error. Statistical analysis was performed using SPSS version 29. Descriptive statistics were used to summarize demographic characteristics and survey responses. The knowledge levels were categorized into poor, moderate, and good. Chi-square analysis was employed to investigate associations between demographic factors and knowledge levels, with a significance level set at p < 0.05, enhancing the robustness of the study's findings. This study included 407 completed eligible responses. About 63.56% of participants were female, with 52.1% employed in pharmacy chains. While 91.2% of pharmacists recognized probiotics' role in immune support, only 30% were aware of their cardiovascular benefits. Moreover, chewing gum was the least known dosage form of probiotics, recognized by only 16.7% of respondents. Additionally, only 57% of the participants recognized liposomes as a dosage form. In practice, most pharmacists recommended storing probiotics at room temperature, accounting for 66.6%. The most prevalent misconception encountered in the pharmacy setting was the belief that probiotics are primarily intended for gastrointestinal tract problems, at 79.1% of the respondents. Regarding perception, the agreement was observed regarding the safety of probiotics for all ages. Perceived barriers included the high cost of probiotics, with the majority (86.5%) indicating this as a significant obstacle, while lack of demand was identified as the minor barrier by 64.6%. Additionally, an association was found at a significance level of p < 0.05 with knowledge, gender, educational level, type and location of pharmacy, and source of information. The study highlights knowledge gaps in pharmacists' understanding of probiotic applications beyond digestive health, particularly cardiovascular health and depression. Targeted educational interventions are necessary to address these gaps. The findings underscore the importance of ongoing professional development for pharmacists, enhancing their role in patient education and the promotion of probiotics for overall health.

Characterization of Human Breast Milk-Derived Limosilactobacillus reuteri MBHC 10138 with Respect to Purine Degradation, Anti-Biofilm, and Anti-Lipid Accumulation Activities.

Background: Human breast milk is a valuable source of potential probiotic candidates. The bacteria isolated from human breast milk play an important role in the development of the infant gut microbiota, exhibiting diverse biological functions. Methods: In this study, Limosilactobacillus reuteri MBHC 10138 isolated from breast milk was characterized in terms of its probiotic safety characteristics and potential efficacy in hyperuricemia, obesity, lipid liver, and dental caries, conditions which Korean consumers seek to manage using probiotics. Results: Strain MBHC 10138 demonstrated a lack of D-lactate and biogenic amine production as well as a lack of bile salt deconjugation and hemolytic activity. It also exhibited susceptibility to common antibiotics, tolerance to simulated oral-gastric-intestinal conditions, and superior biological activity compared to three L. reuteri reference strains, including KACC 11452 and MJ-1, isolated from feces, and a commercial strain isolated from human breast milk. Notably, L. reuteri MBHC 10138 showed high capabilities in assimilating guanosine (69.48%), inosine (81.92%), and adenosine (95.8%), strongly inhibited 92.74% of biofilm formation by Streptococcus mutans, and reduced lipid accumulation by 32% in HepG2 cells. Conclusions: These findings suggest that strain MBHC 10138, isolated from human breast milk, has potential to be developed as a probiotic for managing hyperuricemia, obesity, and dental caries after appropriate in vivo studies.

Structure of Extracellular Vesicles and Their Effect on Bacterial Biofilms Change with the Development of Antibiotic Resistance in the Probiotic Strain Lactiplantibacillus plantarum 8p-a3.

Significant changes in lactobacillus-derived extracellular membrane vesicles, which transfer lipids, polysaccharides, proteins, and nucleic acids, were for the first time observed to accompany the development of resistance to antibiotics (amoxicillin and clarithromycin) in vitro in the probiotic strain Lactiplantibacillus plantarum 8p-a3. The changes occur together with large-scale genome rearrangements, changes in the profile of phenotypic sensitivity to antimicrobials of various groups, and evolution of virulence. Changes in vesicles affected their structure, composition, and activity against biofilms of opportunistic bacteria. The data provide for a better understanding of the molecular mechanisms of microbial survival under selective pressure of antimicrobials, the functional potential of probiotic vesicles, and probiotic safety assessments.

Prevention of Radiotherapy-Induced Enteropathy by Probiotics (PREP): Double-Blind Randomized Placebo-Controlled Trial.

Probiotics are thought to be effective in the treatment of radiation-induced enteropathy (RIE). However, little is known regarding their efficacy in preventing RIE. In this prospective, randomized, double-blinded, placebo-controlled, single-center study, the incidence of grade 2 acute RIE was compared and the safety of probiotics was evaluated. Patients receiving pelvic radiotherapy for a minimum of 40 Gy at the pelvic level were randomized into two groups: (i) a probiotic group receiving Bacillus licheniformis from two weeks before radiotherapy until the end and (ii) a control group receiving a placebo with the same schedule. The toxicities of 234 patients were graded according to the Common Terminology Criteria for Adverse Events v5.0. Grade 1 RIE was observed in 65 (56%) of the probiotics group compared with 75 (64%) of the placebo group. Grade 2 RIE occurred in 30 patients (26%) in the probiotics group compared with 26 (22%) in the placebo group, indicating that probiotics failed in their preventive role compared with placebo (p = 0.493). Medication adherence rates were good, and no difference was observed between the two arms. These findings suggest that B. licheniformis does not significantly prevent RIE.

The Beneficial Effect of Probiotics as an Adjuvant Treatment in Childhood Drug Resistant Epilepsy

Abstract Background Epilepsy is the most frequent chronic neurologic condition in children and every year &amp;gt;4.9 million people develop new-onset epilepsy. The foundation of treatment in epilepsy is drug therapy with anti- seizure medications (ASM). However, about one-third develop drug resistant epilepsy (DRE) due to inability to achieve seizure control despite the use of appropriate ASM. Recent studies indicate that gut dysfunction/dysbiosis is presumably involved in the pathogenesis of and susceptibility to epilepsy. The reconstruction of the intestinal microbiome through probiotic intervention has shown beneficial effects on DRE. Aim of the Work The aim of this study is to study safety and effectiveness of probiotics in controlling epileptic seizures in DRE patients by decreasing frequency and severity of seizures. Patients and Methods This study is a prospective study – Single arm Clinical Trial (Pilot study) conducted on 35 DRE patients at the neurology outpatient clinic, Pediatric Neurology Unit, Ain Shams University, from January to August, 2023, of which 14 (40%) dropped out due to socioeconomic reasons and non-compliance while 21 (60%) patients completed this clinical trial. All the results were calculated based on the 21 patient who completed the study. Patients were supplemented with probiotics for 4 months and assessed pre and post probiotics intake by the following tools: seizure assessment by Chalfont seizure severity scale, a blood sample taken to measure serum sCD14 as an inflammatory marker, an EEG was done and QOLIE-31 was used to asses quality of life. Probiotics (spores of antibiotic resistant Bacillus clausii; Enterogermina 2 Billion @ SANOFI) were used with the following doses daily for 4 months (as per SANOFI’s dose prescribtion): ages 1 year to 2 years: 1 vial per day, ages 2 years to 18 years: 2 vials per day. Results Our study included 21 participants; the median age at the time of the study was 11 years ranging from 2.5 to 15 years of age and the median age of onset of seizure was 7 ranging from 6 months to 12 years. The majority of participants were found to be female 15 (71.4%) and the rest were male 6 (28.4%). This clinical trial shows that probiotics could be a useful supplement in the treatment of DRE where 42.9% of our patients achieved the Therapeutic goal of reduction (≥50%) in the number of seizures &amp; improvement in seizure severity (p-value &amp;lt; 0.001) and frequency (p-value &amp;lt; 0.005). Serum sCD14 levels were withdrawn as an inflammatory marker to understand the potential cause of the improvement in epileptic seizures and their levels were outstandingly improved between pre and post probiotics intake with p-value &amp;lt; 0.001. We also found that quality of life was significantly improved as measured by questionnaire QOLIE31 between pre and post probiotics intake in our patients in all its aspects with total score &amp;lt;0.001. We compared between our 2 main diagnoses (The GDD and Genetic epilepsy) and found that there was higher quality of life in the genetic group than the global developmental delay group with p-value &amp;lt; 0.001 mostly attributing this to the fact that most of the genetic patients had a higher starting point than their counterpart in their developmental history and other aspects. Our patients were also sub-divided into 2 groups based on the effectiveness of the probiotics in improving seizures frequency 50% or more and it was found that the effective group had a lower median age (7 years) than the non-effective group (12.5 years) delineating that younger age responds better to probiotics or management in general. Conclusion This study revealed that probiotics decrease the frequency and severity of seizures and improve the quality of life of drug resistant epilepsy patients. Since this is a pilot study and there are deficient data in this area, more studies are needed to evaluate the applicability, safety and the mechanism of action of probiotics.

Efficacy of Probiotics in Overweight and Obesity Control: An Umbrella Review and Subgroup Meta-Analysis.

Numerous primary and secondary studies have consistently demonstrated that probiotics, including lactobacillus and Bifidobacterium, possess a potential anti-obesity effect. However, it is worth noting that some studies have yielded contrasting results. Considering this, our study aims to present a comprehensive overview of published systematic reviews and meta-analyses, focusing on the efficacy and safety of probiotics in managing obesity. To achieve this objective, we conducted an umbrella review following the PRISMA protocol and Cochrane guidelines. We searched databases such as Embase, PubMed, Cochrane Library, and Google Scholar for relevant systematic reviews and meta-analyses published in English, without imposing any date restrictions. Our inclusion criteria encompassed studies evaluating the anti-obesity impact of probiotics, with a specific focus on changes in body mass index (BMI), fat mass percentage (FMP), body weight (BW), and body fat mass (BFM). These studies were meticulously reviewed by two independent reviewers. Our analysis included five systematic reviews and 18 meta-analyses that met the predefined inclusion and exclusion criteria. The meta-analyses revealed statistically significant reductions in the following parameters: BMI, a decrease of 0.30kg/m2 (p < 0.00001, 95% CI - 0.36 to - 0.25); BFM, a reduction of 0.86kg (p < 0.00001, 95% CI - 1.02 to - 0.71); BW, a decrease of 0.59kg (p < 0.00001, 95% CI - 0.74 to - 0.44); and FMP, a substantial decline of 78% (p < 0.00001, 95% CI - 1.02 to - 0.54). In summary, our umbrella review suggests that existing evidence supports the potential benefits of probiotics in managing obesity and overweight. However, it is essential to acknowledge that the credibility of this evidence is somewhat limited due to the inclusion of studies with poor-quality designs and relatively small participant numbers. To establish the true efficacy of probiotics in obesity management, we recommend conducting robust studies involving larger participant cohorts.

Evaluating the Probiotic Profile, Antioxidant Properties, and Safety of Indigenous Lactobacillus spp. Inhabiting Fermented Green Tender Coconut Water

Evaluating the Probiotic Profile, Antioxidant Properties, and Safety of Indigenous Lactobacillus spp. Inhabiting Fermented Green Tender Coconut Water