Hyperbilirubinemia is a prevalent problem in babies that necessitates medical attention. Probiotic administration as adjuvant therapy may have a positive impact on the pathological neonatal unconjugated hyperbilirubinemia.

Start Date01 Jul 2024

Sponsor / Collaborator

Tanta University

IRCT20231127060200N1 / SuspendedNot ApplicableIIT

Comparative evaluation of Probiotic lozenges tablets with Mouthwash containing fluoride and cetyl pyridinium chloride and chewing gum containing Xylitol on oral Streptococcus mutans coloni

Start Date02 Apr 2024

Sponsor / Collaborator

Rafsanjan University of Medical Sciences

IRCT20231111060016N1 / CompletedPhase 3IIT

The Effect of Lactobacillus Reuteri on Lipid profile in Hypercholesterolemic Adults, a three-blind clinical trial

Start Date06 Dec 2023

Sponsor / Collaborator

Mashhad University of Medical Sciences

100 Clinical Results associated with Lactobacillus reuteri

100 Translational Medicine associated with Lactobacillus reuteri

100 Patents (Medical) associated with Lactobacillus reuteri

1,023

Literatures (Medical) associated with Lactobacillus reuteri

31 Dec 2024·Virulence

Screening optimal DC-targeting peptide to enhance the immune efficacy of recombinant Lactobacillus expressing RHDV VP60

Article

Author: Zhou, Han ; Jiang, Yanping ; Li, Yijing ; Lu, Xiao ; Qiao, Xinyuan ; Guo, Tiantian ; Shan, Zhifu ; Xin, Lingxiang ; Wang, Li ; Cui, Wen ; Kong, Deming ; Gao, Yueyi ; Wang, Xiaona ; Xia, Tian ; Li, Jiaxuan ; Tang, Lijie

Dendritic cells (DCs) present an ideal target for delivering immunogenic cargo due to their potent antigen-presenting capabilities. This targeting approach holds promise in vaccine development by enhancing the efficiency of antigen recognition and capture by DCs. To identify a high-affinity targeting peptide binding to rabbit DCs, rabbit monocyte-derived DCs (raMoDCs) were isolated and cultured, and a novel peptide, HS (HSLRHDYGYPGH), was identified using a phage-displayed peptide library. Alongside HS, two other DC-targeting peptides, KC1 and MY, previously validated in our laboratory, were employed to construct recombinant Lactgobacillus reuteri fusion-expressed rabbit hemorrhagic disease virus (RHDV) capsid protein VP60. These recombinant Lactobacillus strains were named HS-VP60/L. reuteri, KC1-VP60/L. reuteri, and MY-VP60/L. reuteri. The ability of these recombinant Lactobacillus to bind rabbit DCs was evaluated both in vivo and in vitro. Results demonstrated that the DC-targeting peptide KC1 significantly enhanced the capture efficiency of recombinant Lactobacillus by raMoDCs, promoted DC maturation, and increased cytokine secretion. Furthermore, oral administration of KC1-VP60/L. reuteri effectively induced SIgA and IgG production in rabbits, prolonged rabbit survival post-challenge, and reduced RHDV copies in organs. In summary, the DC-targeting peptide KC1 exhibited robust binding to raMoDCs, and recombinant Lactobacillus expressing KC1-VP60 protein antigens efficiently induced systemic and mucosal immune responses in rabbits, conferring protective efficacy against RHDV. This study offers valuable insights for the development of novel RHDV vaccines.

31 Dec 2024·Gut Microbes

Gut microbiota mediate early life stress-induced social dysfunction and anxiety-like behaviors by impairing amino acid transport at the gut

Article

Author: Shi, Lijie ; Zhang, Tiane ; Lin, Chunqiao ; Zhong, Zhuoting ; Zhu, Jiushuang ; He, Yan ; Yang, Youjun ; Huang, Ling ; Ding, Weijun ; Xia, Xiuwen

Early life stress alters gut microbiota and increases the risk of neuropsychiatric disorders, including social deficits and anxiety, in the host. However, the role of gut commensal bacteria in early life stress-induced neurobehavioral abnormalities remains unclear. Using the maternally separated (MS) mice, our research has unveiled a novel aspect of this complex relationship. We discovered that the reduced levels of amino acid transporters in the intestine of MS mice led to low glutamine (Gln) levels in the blood and synaptic dysfunction in the medial prefrontal cortex (mPFC). Abnormally low blood Gln levels limit the brain's availability of Gln, which is required for presynaptic glutamate (Glu) and γ-aminobutyric acid (GABA) replenishment. Furthermore, MS resulted in gut microbiota dysbiosis characterized by a reduction in the relative abundance of Lactobacillus reuteri (L. reuteri). Notably, supplementation with L. reuteri ameliorates neurobehavioral abnormalities in MS mice by increasing intestinal amino acid transport and restoring synaptic transmission in the mPFC. In conclusion, our findings on the role of L. reuteri in regulating intestinal amino acid transport and buffering early life stress-induced behavioral abnormalities provide a novel insight into the microbiota-gut-brain signaling basis for emotional behaviors.

31 Dec 2024·Gut Microbes

Lactobacillaceae differentially impact butyrate-producing gut microbiota to drive CNS autoimmunity

Article

Author: Montgomery, Theresa L. ; Eckstrom, Korin ; Scarborough, Matthew J. ; Heney, Eamonn R. ; Kennedy, Josephine J. ; Krementsov, Dimitry N. ; Toppen, Lucinda C.

BACKGROUNDShort-chain fatty acids (SCFAs), produced by the gut microbiota, are thought to exert an anti-inflammatory effect on the host immune system. The levels of SCFAs and abundance of the microbiota that produce them are depleted in multiple sclerosis (MS), an autoimmune disease of the central nervous system (CNS). The mechanisms leading to this depletion are unknown. Using experimental autoimmune encephalomyelitis (EAE) as a model for MS, we have previously shown that gut microbiomes divergent in their abundance of specific commensal Lactobacillaceae, Limosilactobacillus reuteri (L. reuteri) and Ligilactobacillus murinus (L. murinus), differentially impact CNS autoimmunity. To determine the underlying mechanisms, we employed colonization by L. reuteri and L. murinus in disparate gut microbiome configurations in vivo and in vitro, profiling their impact on gut microbiome composition and metabolism, coupled with modulation of dietary fiber in the EAE model.RESULTSWe show that stable colonization by L. reuteri, but not L. murinus, exacerbates EAE, in conjunction with a significant remodeling of gut microbiome composition, depleting SCFA-producing microbiota, including Lachnospiraceae, Prevotellaceae, and Bifidobacterium, with a net decrease in bacterial metabolic pathways involved in butyrate production. In a minimal microbiome culture model in vitro, L. reuteri directly inhibited SCFA-producer growth and depleted butyrate. Genomic analysis of L. reuteri isolates revealed an enrichment in bacteriocins with known antimicrobial activity against SCFA-producing microbiota. Functionally, provision of excess dietary fiber, as the prebiotic substrate for SCFA production, elevated SCFA levels and abrogated the ability of L. reuteri to exacerbate EAE.CONCLUSTIONSOur data highlight a potential mechanism for reduced SCFAs and their producers in MS through depletion by other members of the gut microbiome, demonstrating that interactions between microbiota can impact CNS autoimmunity in a diet-dependent manner. These data suggest that therapeutic restoration of SCFA levels in MS may require not only dietary intervention, but also modulation of the gut microbiome.

News (Medical) associated with Lactobacillus reuteri

14 Nov 2024

·ibtherapeutics.com

Infant Bacterial Therapeutics AB (publ) Interim report January 1 – September 30, 2024

Message from the CEO This quarter, IBT completed the global Phase 3 clinical trial “The Connection Study” for the drug candidate IBP-9414. On July 8, we reported that the last patient was treated. On August 30, we reported topline data to the market. Since then, we have continued to analyze the data with our experts. Our conclusion is that our drug candidate IBP-9414 meets the requirements for a pharmaceutical product, meaning we have now documented both the potency and safety of IBP-9414. We see that IBP-9414's safety profile is generally very good, in line with, or in some areas even better, than placebo. When we look at the causes of death in infants, we see a clear reduction in the number of deaths in the cardiopulmonary and gastrointestinal areas after IBP-9414 administration when compared to the children receiving placebo. See figure 1. Figure 1: Reported causes of death grouped by organ class in “The Connection Study” If we look at survival as a function of time, we see an clear effect of IBP-9414 after two weeks of treatment. See figure 2 (in attachment) on the Y-axis we see survival and on the X-axis we see the number of days after the first dose is administered. The overall reduction in mortality of 27% in the IBP-9414 treatment group compared to the placebo group for all preterm infants in the phase 3 study is clinically relevant. In addition, when examining deaths occurring after 14 days of treatment, the relative risk of death is further reduced to 46%. These are fantastic results and as there is no treatment alternative on the market, we at IBT are highly motivated to continue our work to register our product. After further analysis of the study data, scientifically accepted reasons have emerged as to why it has been difficult to measure our primary endpoints in the study. There are different pathways for how a product can be registered as a medicine. We will therefore have a meeting with the FDA, which is scheduled for December 2024. Then we will update timetables for the remaining parts of IBP-9414's development work. In parallel with our communication with the authorities, we are ensuring that we can produce large volumes of IBP-9414 to a high standard of quality. We are expanding our supplier network for manufacturing and product analysis. The first commercial batches are planned to be produced in 2025. Another ongoing activity is the publication of the full results from “The Connection study”, IBT's data from the study will be presented at Hot Topics in Neonatology, December 9, by Professor Josef Neu who is also the principal investigator of the study. IBT also aims to publish the results in several scientific publications as soon as possible. On October 25th, IBT was the only company invited to participate in a one-day meeting organized by the US authorities in Washington DC. The purpose of the meeting was to bring together academia, government and industry to discuss the Live Biotheapeutic Products class of drugs and how such products can be developed to prevent NEC. Clinical results for IBP-9414 were also presented during the meeting. In conclusion, I would like to thank all the staff in the 95 hospitals around the world who collected data for the infants. I would also like to extend a very big thank you to the IBT staff who executed the largest randomized study ever conducted on preterm infants in a very professional manner. We now look to the future with confidence, as IBT has no doubt that the results of our phase 3 study demonstrate that premature babies do better with IBP-9414 than without it. Stockholm November 13, 2024 Staffan Strömberg, CEO Financial overview for the period * Operational income includes exchange rate effects on foreign currency deposits to secure future outflows during the third quarter amounting to KSEK -4 280 (-448) and during the reporting period amounting to SEK -108 (7 313) Significant events during the third quarter (Jul-Sep) On July 8, 2024, IBT announced that the last patient in the global Phase 3 clinical program “The Connection Study” has been treated. This means that the clinical development program is completed. On August 15, 2024, IBT announced they had received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for the drug candidate IBP-9414. On August 30, 2024, IBT announced phase III study didn´t showed significant effects on the primary endpoints but a significant reduction in the secondary endpoint, all-cause mortality. Significant events during the reporting period (Jan-Sep) On April 4, 2024, IBT announced that the last patient out of a total of 2,158 premature infants had been enrolled in the global Phase 3 clinical program (“The Connection Study”) for the development of IBP-9414. Results from “The Connection Study” were expected Q3 2024. Selected financial data Contacts Staffan Strömberg, CEO Maria Ekdahl, CFO info@ibtherapeutics.com +46 76 219 37 38 About Us Infant Bacterial Therapeutics AB (“IBT”) is a public company domiciled in Stockholm. The company’s Class B shares are since September 10, 2018, listed on Nasdaq Stockholm (IBTB). IBT is a pharmaceutical company whose purpose is to develop and commercialize drugs for diseases affecting premature babies. During the 12 years of drug development IBT has gained unique expertise in the field of drugs using live bacteria as active substances. This is a key competitive factor for our development programs. IBT's main focus is the drug candidate IBP-9414, a formulated bacterial strain naturally found in human breast milk. IBP-9414, is expected to be the first product in the new class of biologics called "Live Biotherapeutic Products" for premature infants. The drug development of IBP-9414 is currently in its final stages for this important product for premature babies. The portfolio also includes additional drug candidates, IBP-1016, IBP-1118 and IBP-1122. IBP-1016, for the treatment of gastroschisis, a life-threatening and rare disorder in which children are born with externalized gastrointestinal organs. IBP-1118 to prevent retinopathy of prematurity (ROP), one of the leading causes of blindness in premature babies, and IBP-1122 to eliminate vancomycin-resistant enterococci (VRE), which cause antibiotic-resistant hospital infections. Through the development of these drugs, IBT can address medical needs where no sufficient treatments are available.

Phase 3Clinical Result

30 Aug 2024

·ibtherapeutics.com

IBT’s phase III study shows no significant effects on the primary endpoints but a significant reduction in the secondary endpoint, all-cause mortality

IBT has conducted a phase III study comprising 2153 premature infants for five years. The objective of the study has been to show that the company's drug candidate IBP-9414, a bacterial strain found naturally in human breast milk, can improve the health of premature infants by preventing necrotizing enterocolitis (NEC) and improve premature infants' gastrointestinal function (measured as time to Sustained Feeding Tolerance, SFT) and, as a secondary objective, reduce death. The results of the study have now been analyzed according to the pre-specified statistical analysis plan. Although these analysis showed positive trends, there were no statistical significance for the two primary endpoints: prevention of necrotizing enterocolitis (NEC), active group: 8.7% vs placebo group: 10.2% (p=0.24) and SFT, active group: 16 days vs placebo group: 17 days (p=0.07). Importantly, there was a significant reduction in the secondary endpoint of all-cause mortality, active group: 6.2% vs placebo group: 8.5% (p=0.04), corresponding to a significant risk reduction of 27%, which meant that in reality 23 infants’ lives were spared by the administration of IBP-9414 in the study. IBT will continue the development towards pharmaceutical registration, considering that the study showed statistical significance on all-cause mortality. The previous communicated timeline for the registration might be affected and IBT will revert with an update if any changes will occur. The risk reduction of 27% in mortality is a substantial effect size and comparable to currently available pharmaceutical products, for example, surfactants used in the neonatal intensive care units. The effect of IBP-9414 could potentially save the lives of thousands of infants per year and is the only Live Biopharmaceutical candidate that has shown a strong advantage in saving premature infants’ lives. Furthermore the study shows that giving IBP-9414 to these very vulnerable premature infants does not cause any safety issues, including the risk of sepsis which has been a concern expressed by the FDA for the use of probiotic products in preterm infants. “It is becoming clear to the scientific community that NEC is a poorly defined diagnosis representing several different processes. This is the likely reason for the results obtained on the NEC endpoint. Regarding the SFT endpoint, feeding patterns between intensive care units differed more than expected, which could explain the SFT results. The observed difference of 27% in lowered mortality in the active group is exciting and cannot be ignored,” says Josef Neu, Professor of Pediatrics at the University of Florida and principal investigator of the study. “Over the years, neonatal intensive care has significantly improved the survival of preterm infants. Fifty years ago, only 5-10% of the smallest babies survived. Today, the corresponding survival rate is much higher at 80%. Several factors, such as mechanical ventilation and pharmaceuticals like surfactants, have significantly contributed to this positive development. With our study data, I expect that IBP-9414 could be the next major improvement targeting the gut, as it is now established that the product increases the survival rate of premature infants. I believe the extraordinary and unexpected large effect on survival is even more important than potential improvements in NEC and SFT. We are extremely grateful for all the excellent work done by our employees and the medical teams in approximately 100 hospitals involved in the study and special thank you to all families who have allowed us to include their infants in the study," says IBT’s CEO, Staffan Strömberg. “Because mortality is considerably lower in the active group, we have decided to pursue our endeavors to register IBP-9414 as a drug. IBT’s financial situation is such that we have sufficient resources to continue our development work. IBT's cash position was SEK 272 million at the end of the second quarter. I am confident our competent staff led by Staffan Strömberg will spare no effort to register the product as a pharmaceutical thereby helping many premature infants in the future,” says Peter Rothschild, IBT’s chairman. This information is information that Infant Bacterial Therapeutics is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-08-30 18:38 CEST.

Clinical ResultPhase 3

28 Aug 2024

·ibtherapeutics.com

Infant Bacterial Therapeutics AB (publ), Interim report January 1 – June 30, 2024

Message from the CEO IBT has announced the crucial results from the global clinical phase 3 study “The Connection Study” for our drug project IBP-9414 are expected in Q3 2024. On the 8th of July, we reported that the last patient had completed treatment. During the summer, our focus has been on ensuring the transfer of all study data to IBT’s database, comprising over half a million entries in so-called CRFs (case report forms). The database must then be converted into a result through the work of statisticians. It is of utmost importance that the database is accurate, therefore IBT is carefully scrutinizing the CRF data to detect any discrepancies. In August, we completed the review and implemented the next step called “database lock”. By locking our database it means that we are satisfied with the data quality and have passed the baton to the statisticians. The results will be analyzed to understand the medical benefits for premature infants. We plan to collaborate with international clinical experts for this analysis, after which we will publicly announce the results through a press release. It is not long now before we will finally know the effectiveness and safety of IBP-9414. Regardless of whether we obtain the good results we expect from the study, I want to express my gratitude to all of IBT's employees in Sweden, Europe and the United States. Under Anders Kronström's excellent leadership, they have handled this extensive clinical study brilliantly. There have been major challenges, such as a Covid pandemic, but through determination combined with innovative thinking, we have managed to complete the study. Many thanks from me. This spring, the regulatory work began to prepare IBT's drug application for IBP-9414. The work has intensified, and more sections are ready. As soon as we have received results from “The Connection Study” IBT intends to contact the FDA and discuss how they want us to submit our data with the objective of reaching the market as soon as possible. There is still a lot of interest in our study and what IBP-9414 will mean for the treatment of premature infants. IBT is further developing its interactions with Key Opinion Leaders in the US as well as in Europe. We will also increase the pace of our commercial work and will continue work to ensure commercial production after we have received the results of our study. The recent approval of IBT's patent application for IBP-9414 in the US strengthens intellectual property protection in this crucial market, complementing its existing orphan drug designation and biological drug classification. It is worth mentioning that we have continued to work on IBP-1122 and IBP-1118 and that we are planning to meet the FDA to discuss development programs this autumn. It will not be long until we can hopefully show that IBT can help premature infants while also creating value for IBT’s shareholders. Expect to hear soon how the largest randomized study ever conducted in preterm infants turns out. Stockholm August 27, 2024 Staffan Strömberg, CEO Financial overview for the period Second quarter (Apr-Jun) 2024 Net sales KSEK 0 (0) Operating income KSEK -44 279* (-30 952) Earnings per share before and after dilution SEK -3.17 (-2.57) Reporting period (Jan-Jun) 2024 Net sales KSEK 0 (0) Operating income KSEK -74 077* (-55 247) Earnings per share before and after dilution SEK -5.70 (-4.57) * Operational income includes exchange rate effects on foreign currency deposits to secure future outflows during the second quarter amounting to KSEK -1 150 (8 412) and during the reporting period amounting to SEK 4 173 (7 760) Significant events during the second quarter (Apr-Jun) On April 4, 2024, IBT announced that the last patient out of a total of 2,158 premature infants has been enrolled in the global Phase 3 clinical program (“The Connection Study”) for the development of IBP-9414. Results from “The Connection study” are expected Q3 2024. Significant events after the reporting period On July 8, 2024, IBT announced that the last patient in the global Phase 3 clinical program “The Connection Study” has been treated. This means that the clinical development program is completed.8 On August 15, 2024, IBT announced that they had received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for the drug candidate IBP-9414. Selected financial data This information is information that Infant Bacterial Therapeutics is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-08-28 08:30 CEST.

Phase 3Orphan Drug

100 Deals associated with Lactobacillus reuteri

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KEGG	Wiki	ATC	Drug Bank
-	Lactobacillus reuteri	A07FA01	DB14224

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Indication	Country/Location	Organization	Date
Gastrointestinal Diseases	IN	BioGaia AB	30 Apr 2009

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Indication	Highest Phase	Country/Location	Organization	Date
Obstetric Labor, Premature	Phase 3	BG	Infant Bacterial Therapeutics AB	04 Jul 2019
Obstetric Labor, Premature	Phase 3	RO	Infant Bacterial Therapeutics AB	04 Jul 2019
Obstetric Labor, Premature	Phase 3	US	Infant Bacterial Therapeutics AB	04 Jul 2019
Obstetric Labor, Premature	Phase 3	IL	Infant Bacterial Therapeutics AB	04 Jul 2019
Obstetric Labor, Premature	Phase 3	FR	Infant Bacterial Therapeutics AB	04 Jul 2019
Obstetric Labor, Premature	Phase 3	ES	Infant Bacterial Therapeutics AB	04 Jul 2019
Obstetric Labor, Premature	Phase 3	RS	Infant Bacterial Therapeutics AB	04 Jul 2019
Obstetric Labor, Premature	Phase 3	PL	Infant Bacterial Therapeutics AB	04 Jul 2019
Obstetric Labor, Premature	Phase 3	GB	Infant Bacterial Therapeutics AB	04 Jul 2019
Obstetric Labor, Premature	Phase 3	HU	Infant Bacterial Therapeutics AB	04 Jul 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03978000 (Company_Website) Manual	Phase 3	Enterocolitis, Necrotizing	2,117	IBP-9414	(kqdqbiaksb) = aughoytdti xvtrlkezue (kndzatynfg ) View more	Positive	14 Nov 2024
				Placebo	(kqdqbiaksb) = gqujzoeqmb xvtrlkezue (kndzatynfg ) View more
NCT03978000 (Company_Website) Manual	Phase 3	Enterocolitis, Necrotizing	2,153	IBP-9414	liyaikxqxc(uqgwpiekbw) = fegybiuqqy ivcchfvpsf (bvjcnfkwcr ) View more	Negative	30 Aug 2024
				Placebo	liyaikxqxc(uqgwpiekbw) = bebszlvqsz ivcchfvpsf (bvjcnfkwcr ) View more
NCT02124122 (CTgov)	Phase 1	-	60	Lactobacillus reuteri (Lactobacillus)	jlzhorubvc(bbidnoxmlt) = tnoxnekphx hlryhictfc (bfdgxjdqts, wlyiqopzkk - lepscvgdbn) View more	-	24 Apr 2017
				Placebo (Placebo)	jlzhorubvc(bbidnoxmlt) = atqmmkbicg hlryhictfc (bfdgxjdqts, smwgundrgx - aghsaaxixk) View more
NCT01541046 (Pubmed \| J Postgrad Med)	Phase 2	Colic	52	Lactobacillus reuteri DSM 17938	hfuyobxnjv(rouzkpppct) = hfzbjavoyv otqencfirg (jbixsmwacl )	Positive	01 Jan 2015
				Placebo	hfuyobxnjv(rouzkpppct) = tktsnhijwc otqencfirg (jbixsmwacl )
NCT01531179 (Pubmed \| Arch Dis Child Fetal Neonatal Ed)	Phase 3	Enterocolitis, Necrotizing	400	Lactobacillus reuteri	(dbmqnkygoe) = fyrtceylym cfuojhonph (ujzouyrhyi ) View more	-	01 Mar 2014
				Lactobacillus Reuteri (Placebo)	(dbmqnkygoe) = pmjjochkwn cfuojhonph (ujzouyrhyi ) View more
Pubmed \| J Nutr	Not Applicable	-	494	Probiotics Lactobacillus reuteri DSM 17938 (Low-lactose milk with low calcium content)	gkpkiiefbh(vuweyasxxw) = wspsztehqa rikdeaiksg (ocohwfnxmn, 0.01 - 0.05) View more	-	01 Jul 2013
				Regular calcium with Lactobacillus casei CRL 431	veqafsehfg(grzbraduxk) = gbviyugfnp jbncooozlk (xesxsmriiy, 0.001 - 0.05)

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