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

1,016

Literatures (Medical) associated with Lactobacillus reuteri

31 Dec 2024·Gut Microbes

Prebiotic inulin controls Th17 cells mediated central nervous system autoimmunity through modulating the gut microbiota and short chain fatty acids

Article

Author: Xu, Tianhao ; Wang, Huijun ; Yang, Liu ; Huang, Fei ; Wu, Hui ; Wu, Xiaojun ; Wang, Yongjun ; Han, Xinyan ; Li, Ning ; Shi, Songshan ; Wang, Shunchun ; Ruan, Ming

Multiple sclerosis (MS) is an autoimmune disease characterized by inflammatory demyelination occurring in the central nervous system (CNS). Inulin is a common prebiotic that can improve metabolic disorders by modulating the gut microbiota. However, its capacity to affect CNS autoimmunity is poorly recognized. Experimental autoimmune encephalomyelitis (EAE) is a classical mouse model of MS. Herein, we found that oral administration of inulin ameliorated the severity EAE in mice, accompanied by reductions in inflammatory cell infiltration and demyelination in the CNS. These reductions were associated with decreased proportion and numbers of Th17 cells in brain and spleen. Consistent with the findings, the serum concentrations of IL-17, IL-6, and TNF-α were reduced in inulin treated EAE mice. Moreover, the proliferation of auto-reactive lymphocytes, against MOG_35-55 antigen, was attenuated ex vivo. Mechanistically, inulin treatment altered the composition of gut microbiota. It increased Lactobacillus and Dubosiella whereas decreased g_Prevotellaceae_NK3B31_group at the genus level, alongside with elevated concentration of butyric acid in fecal content and serum. In vitro, butyrate, but not inulin, could inhibit the activation of MOG_35-55 stimulated lymphocytes. Furthermore, fecal microbiota transplantation assay confirmed that fecal contents of inulin-treated normal mice had an ameliorative effect on EAE mice. In contrast, antibiotic cocktail (ABX) treatment diminished the therapeutic effect of inulin in EAE mice as well as the reduction of Th17 cells, while supplementation with Lactobacillus reuteri restored the amelioration effect. These results confirmed that the attenuation of inulin on Th17 cells and inflammatory demyelination in EAE mice was dependent on its modulation on gut microbiota and metabolites. Our findings provide a potential therapeutic regimen for prebiotic inulin supplementation in patients with multiple sclerosis.

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 ; Shan, Zhifu ; Guo, Tiantian ; Xin, Lingxiang ; Cui, Wen ; Wang, Li ; 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 ; He, Yan ; Zhu, Jiushuang ; 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.

News (Medical) associated with Lactobacillus reuteri

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

15 Aug 2024

·ibtherapeutics.com

Patent for Infant Bacterial Therapeutics has been approved in the USA

Infant Bacterial Therapeutics AB (IBT) announces today that it has been granted a Notice of Allowance from the US Patent and Trademark Office (USPTO), meaning that IBT’s patent application has been approved. The patent pertains to the drug candidate IBP-9414, which has been developed by IBT for the prevention of Necrotizing Enterocolitis (NEC) and to improve the nutritional intake and development of premature infants. The invention encompasses a unique method of activating freeze-dried bacteria. The patent reinforces the existing intellectual property protection for IBT’s drug candidate IBP-9414. IBT has been granted orphan drug status in both the USA and the EU. Furthermore, IBP-9414 is a biologic medicine which further strengthens protection through data exclusivity in the USA and EU. The plan is to launch IBP-9414 on the US market as soon as market authorization is obtained. The phase III clinical study was completed in July 2024, and the study results are expected this quarter. CEO Staffan Strömberg comments, “The intellectual property protection for IBP-9414 was already strong before this US patent was approved, as the project had already been granted Orphan Drug Status and is a biologic. The US market is the largest and most important. Being able to strengthen IP protection and additionally extend its duration is great news.” 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 2024-08-15 16:44 CEST.

Orphan DrugPhase 3Qualified Infectious Disease ProductMicrobial therapy

100 Deals associated with Lactobacillus reuteri

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

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10 top R&D records.

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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02124122 (CTgov)	Phase 1	-	60	Lactobacillus reuteri (Lactobacillus)	nqmysrunlt(wvyfduowse) = iqdysjrulg vptipravcy (ovscxoxbli, claytmamhb - lbjnixndwo) View more	-	24 Apr 2017
				Placebo (Placebo)	nqmysrunlt(wvyfduowse) = sorgnkejnp vptipravcy (ovscxoxbli, yjkvcorpop - sidwfuvmqc) View more
NCT01541046 (Pubmed \| J Postgrad Med)	Phase 2	Colic	52	Lactobacillus reuteri DSM 17938	fgypoxfsqk(hpxirurudu) = bycslvuvrc sdlstvsajq (mycmnfzvkw )	Positive	01 Jan 2015
				Placebo	fgypoxfsqk(hpxirurudu) = kfmvrdyysn sdlstvsajq (mycmnfzvkw )
NCT01531179 (Pubmed \| Arch Dis Child Fetal Neonatal Ed)	Phase 3	Enterocolitis, Necrotizing	400	Lactobacillus reuteri	(yqrgunaqvy) = cqajhbptxu jrfbmormvy (jizfiyhhav ) View more	-	01 Mar 2014
				Lactobacillus Reuteri (Placebo)	(yqrgunaqvy) = ikjjbdvgik jrfbmormvy (jizfiyhhav ) View more
Pubmed \| J Nutr	Not Applicable	-	494	Probiotics Lactobacillus reuteri DSM 17938 (Low-lactose milk with low calcium content)	mgncbnnzop(itsdmirdan) = utigghakle wjcvrzcyuq (zlkbjfpgdn, 0.01 - 0.05) View more	-	01 Jul 2013
				Regular calcium with Lactobacillus casei CRL 431	tutzxbvkpb(gvgksavvak) = jtarpamhis ignmemrvkp (jsyapkfflx, 0.001 - 0.05)

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