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 Applicable

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 3

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

953

Literatures (Medical) associated with Lactobacillus reuteri

01 Mar 2024·Microbial pathogenesis

Lactobacillus reuteri derived from horse alleviates Escherichia coli-induced diarrhea by modulating gut microbiota

Article

Author: Su, Zhonghua ; Ullah, Qudrat ; Wujin, Cuomu ; Zeng, Jiangyong ; Wang, Dongjing

Diarrhea is a prevalent health issue in farm animals and poses a significant challenge to the progress of animal husbandry. Recent evidence suggested that probiotics can alleviate diarrhea by maintaining gut microbial balance and enhancing the integrity of the intestinal barrier. However, there is a scarcity of studies investigating the efficacy of equine Lactobacillus reuteri in relieving E. coli-induced diarrhea. Hence, this study aimed to examine the potential of equine-derived Lactobacillus reuteri in alleviating E. coli diarrhea from the perspective of gut microbiota. Results demonstrated that supplementation of Lactobacillus reuteri had the potential to alleviate diarrhea induced by E. coli infection and restore the decline of tight junction genes, such as Claudin-1 and ZO-1. Additionally, Lactobacillus reuteri supplementation can restore the expression of inflammatory factors (IL-6, IL-10, TNF-α, and IFN-γ) and reduce colon inflammatory damage. Diversity analysis, based on amplicon sequencing, revealed a significant reduction in the diversity of gut microbiota during E. coli-induced diarrhea. Moreover, there were notable statistical differences in the composition and structure of gut microbiota among the different treatment groups. E. coli could induce gut microbial dysbiosis by decreasing the abundance of beneficial bacteria, including Lactobacillus, Bifidobacterium, Ligilactobacillus, Enterorhabdus, and Lachnospiraceae_UCG_001, in comparison to the control group. Conversely, supplementation with Lactobacillus reuteri could restore the abundance of beneficial bacteria and increase the diversity of the gut microbiota, thereby reshaping gut microbiota. Additionally, we also observed that supplementation with Lactobacillus reuteri alone improved the gut microbial composition and structure. In summary, the findings suggest that Lactobacillus reuteri can alleviate E. coli-induced diarrhea by preserving the integrity of the intestinal barrier and modulating the composition of the gut microbiota. These results not only contribute to understanding of the mechanism underlying the beneficial effects of Lactobacillus reuteri in relieving diarrhea, but also provide valuable insights for the development of probiotic products aimed at alleviating diarrheal diseases.

01 Mar 2024·Food chemistry: X

Comparison and evaluation of L. reuteri and L. rhamnosus-fermented egg yolk on the physicochemical and flavor properties of cookies

Article

Author: Deng, Xiaofan ; Liu, Yuanjing ; Jia, Jie ; Liu, Xuebo ; Duan, Xiang ; Jia, Xin ; Guo, Chunfeng

The study aims to explore an effective approach to improve the sensory quality and consumer satisfaction of cookies in the food industry. L. reuteri and L. rhamnosus were chosen to ferment egg yolk and their effects on dough properties and physicochemical properties, flavor, texture, color, and sensory acceptability of cookies were studied. Results show that the utilization of fermented egg yolk significantly decreased baking loss and increased spread factor of cookies. GC-MS analysis indicates different Lactobacillus species enhanced cookie flavor through unique mechanisms. Texture analysis shows cookies prepared with L. rhamnosus-fermented egg yolk had significantly lower hardness (1807.12 g) than control cookies (2028.34 g). Sensory evaluation reveals the L. reuteri-fermented egg yolk significantly improved the overall acceptability of cookies by enhancing appearance, flavor, and mouthfeel scores. These findings have practical implications for food manufacturers seeking to enhance their product's quality and appeal, thereby gaining a competitive edge in the market.

01 Mar 2024·Journal of hypertension

Lactobacillus induced by irbesartan on spontaneously hypertensive rat contribute to its antihypertensive effect

Article

Author: Yang, Xuechun ; Wu, Tianyuan ; Zhang, Wei ; Xiong, Yalan ; Zhou, Jian ; Li, Xiong ; Li, Qing ; Liu, Yujie ; Peng, Yilei ; Shu, Yan ; Chen, Zhi ; Xiong, Yanling ; Zhou, Honghao ; He, Yanping

Objective::

Hypertension is linked to gut dysbiosis. Here, the impact of the angiotensin receptor antagonist irbesartan on the gut microbiota of spontaneously hypertensive rats (SHR) were investigated. In addition, we assessed their contribution to its antihypertensive effect.

Methods::

Eight-week-old Wistar–Kyoto (WKY) rats and SHR were administered irbesartan for 8 weeks. Fecal microbiota transplantation (FMT) was performed from SHR treated with irbesartan or untreated SHR to recipient untreated SHR. The preventive effect of Lactobacillus on hypertension in SHR was evaluated. Blood pressure (BP) was calculated using a tail-sleeve sphygmomanometer. To better assess the composition of the gut microbiota, the V3–V4 region of the 16S rRNA gene was amplified while short-chain fatty acids (SCFAs) in feces were tested by liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS).

Results::

Irbesartan restored gut dysbiosis, increased the abundance of Lactobacillus, and improved anti-inflammatory ability, antioxidative ability, intestinal integrity, and intestinal inflammation in SHR. The microbiota in SHR-treated irbesartan could reduce BP and improve antioxidative ability and gut integrity in SHR. Lactobacillus johnsonii (L. johnsonii) and Lactobacillus reuteri (L. reuteri) reduced BP, restored gut dysbiosis and improved anti-inflammatory ability, antioxidative ability, intestinal integrity in SHR. Most notably, irbesartan, L. johnsonii, and L. reuteri can significantly increase SCFA content in SHR feces.

Conclusion::

The current study demonstrated that irbesartan treatment ameliorated gut dysbiosis in SHR. Irbesartan induced alterations in gut microbiota, with increased prevalence of Lactobacillus.

News (Medical) associated with Lactobacillus reuteri

02 Nov 2023

·www.sciencedaily.com

Research connecting gut bacteria and oxytocin provides a new mechanism for microbiome-promoted health benefits

Researchers found that the hormone oxytocin, known to be involved in regulating feeding and social behavior and until now to be produced mostly in the brain, is also produced in the human intestine. Furthermore, gut resident bacteria L. reuteri can affect the production of gut-made oxytocin, providing the first insights into a mechanism by which these bacteria can influence human health. The gut microbiome, a community of trillions of microbes living in the human intestines, has an increasing reputation for affecting not only gut health but also the health of organs distant from the gut. For most microbes in the intestine, the details of how they can affect other organs remain unclear, but for gut resident bacteria L. reuteri the pieces of the puzzle are beginning to fall into place. "L. reuteri is one of such bacteria that can affect more than one organ in the body," said co-corresponding author Dr. Sara Di Rienzi, assistant professor of molecular virology and microbiology at Baylor. "Researchers have found that these bacteria reduce gut inflammation in adults and rodent models, suppress bone loss in animal models of osteoporosis and in a human clinical trial, promote skin wound healing in mice and humans and improve social behavior in six mouse models of autism spectrum disorder." Of those effects of L. reuteri, the abilities to promote social behavior and wound healing have been shown to require signaling by the hormone oxytocin, but little was known about how this occurs. "We investigated the link connecting L. reuteri, oxytocin and distant organs such as the brain and uncovered unexpected findings," said first author Dr. Heather Danhof, assistant professor of molecular virology and microbiology at Baylor. "Oxytocin is mostly produced in the hypothalamus, a brain region involved in regulating feeding and social behavior, as well as in other organs. Given that other brain-produced hormones also are made in the gut, we tested the novel idea that oxytocin itself was also produced in the intestinal epithelium where L. reuteri typically resides." The researchers built up their case step by step. First, they reviewed single-cell RNA-Seq datasets of the intestinal epithelium, which show which genes are expressed in that tissue. They found that oxytocin genes are expressed in the epithelium of various species, including mice, macaques and humans. Then, using fluorescence microscopy, the team revealed the presence of oxytocin directly on human intestinal organoids, also called mini guts, which are laboratory models of intestinal tissue that recapitulate many of its functions and structure. "Finally, a big moment was when we visualized oxytocin in human intestinal tissue samples, demonstrating oxytocin as an intestinal hormone," Di Rienzi said. "We also determined a mechanism by which L. reuteri mediates oxytocin secretion from human intestinal tissue and human intestinal organoids," Danhof said. "L. reuteri stimulates enteroendocrine cells in the intestine to release the gut hormone secretin, which in turn stimulates another intestinal cell type, the enterocyte, to release oxytocin." "We are excited about these findings," said co-corresponding author Dr. Robert Britton, professor of molecular virology and microbiology and member of the Dan L Duncan Comprehensive Cancer Center at Baylor. "These bacteria have positive effects in various parts of the body, but it was not understood how that happened. Our findings reveal that oxytocin is also produced in the gut and a new mechanism by which L. reuteri affects oxytocin secretion. Now, we are working to identify potential treatments for autism spectrum disorders using a new mouse model deficient in intestinal oxytocin to gain a new understanding of the connection between oxytocin produced in the gut, social behavior and the brain."

25 Aug 2023

·www.globenewswire.com

Infant Bacterial Therapeutics AB (publ) Interim report January 1 - June 30, 2023

Message from the CEO Our Phase-III study, the largest of its kind ever conducted, is progressing across 88 hospitals in ten countries. We have now recruited 85% of the patients (1824 out of the planned 2158), and with the current rate of approximately 75 patients per month, we anticipate completing the recruitment by the end of the year. In June, the Data Monitoring Committee (DMC) concluded its scheduled safety analysis of data from the first 1400 recruited patients. The DMC's conclusion is that the study can proceed as planned without any reservations. The DMC also conducted a futility analysis to determine if the trial has the potential to achieve statistically significant results, and once again, the conclusion was that the clinical work can continue as scheduled. No further DMC reviews are planned, and we are now approaching the conclusion of our extensive study. In the study, children are divided into two groups. In one group, the children receive a placebo, a treatment intended to have no effect on the patient. In the other group, the children receive IBP-9414. Both the effectiveness and safety-related observations are then compared between the two groups. IBT has, as is customary in pharmaceutical studies, reached agreements with both the FDA (the U.S. pharmaceutical authority) and the EMA (its European counterpart) that no comparisons should be made before the study is concluded. Therefore, the study has been intentionally designed so that, at this point, observations from the study cannot be attributed to a specific treatment group. However, what we can do in the present time is analyze data from a "total" perspective. During the spring, we have analyzed the amount of food the children receive. We have been able to identify several clinical factors that influence the amount of food the children receive. Our findings have been accepted for publication in the American Journal of Perinatology. One of the efficacy endpoints (one of two primary endpoints) examines how IBP-9414 improves Sustained Feeding Tolerance (SFT). The amount of food administered by the doctors to the children is one of three factors included in the SFT endpoint. The other two factors are whether the children receive intravenous feeding and how the children gain weight. The publication in the American Journal of Perinatology serves as confirmation that we have appropriately designed our Phase III study. We are pleased that the European Patent Office has approved IBT's application covering Lactobacillus reuteri. This patent enhances IBT's exclusivity in the critical European market until 2036. Our product portfolio initiatives continue to progress. IBT has been granted orphan drug status for our Gastroschisis program, IBT-1016. This marks the first instance in which a developmental program has received orphan drug designation for the treatment of Gastroschisis in the United States. IBT decided at an extraordinary general meeting to conduct a rights issue to prepare for the launch of IBP-9414 and to initiate the development work of one or more of the other IBT portfolio projects. In July, IBT announced that the issuance was oversubscribed, raising approximately 100 million SEK before issuance costs, which is certainly gratifying. Finally, I want to express my deep gratitude to IBT's colleagues for all contributions during the first half of the year. It is truly remarkable what you have achieved. Now, we have the goal within reach. Stockholm, August 24th, 2023 Staffan Strömberg, CEO Financial overview for the period Second quarter (Apr-Jun) 2023 Net sales KSEK 0 (0) Operating income KSEK -30 952* (1 758)Earnings per share before and after dilution SEK -2.57 (0.15) Reporting period (Jan-Jun) 2023 Net sales KSEK 0 (0) Operating income KSEK -55 247* (-17 305)Earnings per share before and after dilution SEK -4.57 (-1.56) * Operational income includes exchange rate effects on foreign currency deposits for the purpose of securing future outflows during the second quarter amounting to KSEK 8 412 (19 979) and during the reporting period amounting to KSEK 7 760 (26 231) Significant events during the second quarter (Apr-Jun) On May 16, 2023, IBT decided on a rights issue and called for an extraordinary general meeting of shareholders.On June 9, 2023, the Extraordinary General Meeting resolved to approve the Board's decision to increase the share capital by issuing new shares with pre-emptive rights for the company's shareholders.On June 15, 2023 IBT announced that the European Patent Office has approved its patent application for Lactobacillus reuteri. The patent covers the drug candidate IBP-9414On June 21, 2023, it was announced that the Data Monitoring Committee (DMC) conducted a planned safety analysis, without objections. At the same time, a planned futility analysis was also conducted and was positive, which means that IBT is continuing the study as planned. Significant events during the reporting period (Jan-Jun) On January 12, 2023, it was announced that IBT acquired a probiotic pharmaceutical platform that can prevent antibiotic-resistant hospital infections.In January 2023, IBT published new results in the British Journal of Gastroenterology validating Sustained Feeding Tolerance (SFT) as a relevant primary endpoint in “The Connection Study”.In March 2023, IBT announced that the last cohort would open for recruitment. This third cohort will include infants with a birth weight between 1001 grams and 1500 grams. Significant events after the reporting period On July 3, 2023, IBT announced that the product IBP-1016 for gastroschisis had been granted orphan drug status.On July 4, 2023, IBT announced the outcome of the rights issue. The issue provided IBT with approximately SEK 101 million before deduction of transaction costs. After the rights issue, the number of shares and votes in the company changed. The new number of shares now amounts to 13,471,420, of which 453,283 A-shares and 13,018,137 B-shares. Selected financial data 000´s20232022202320222022 Apr-JunApr-JunJan-JunJan-JunJan-DecNet Sales-----Other income--13312Operating profit / loss-30 9521 758-55 247-17 305-65 808Result after tax-28 8201 648-51 288-17 553-65 451Total assets317 390400 007317 390400 007349 619Cash flow for the period-14 138-28 182-42 647-39 007-83 911Cash flow per share for the period (SEK)-1.26-2.51-3.80-3.47-7.47Cash 300 953373 976300 953373 976335 840Earnings per share before and after dilution (SEK)-2.570.15-4.57-1.56-5.83Equity per share (SEK)25.0233.8125.0233.8129.55Equity ratio (%)89%95%89%95%95% IBT in brief Infant Bacterial Therapeutics AB (“IBT”) is a public company domiciled in Stockholm. Thecompany’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 market drugs targetingdiseases affecting prematurely born infants or caused by antibiotic-resistant bacteria. IBT’s main focus is on its drug candidate IBP-9414, whose development program is designedto demonstrate a reduced incidence of necrotizing enterocolitis (NEC) and whetherprematurely born infants achieve improved sustained feeding tolerance (SFT) when treatedwith the active substance Lactobacillus reuteri, a bacterial strain naturally found in humanbreast milk. IBP-9414 is currently in an ongoing registration-enabling the pivotal Phase III studyand is the company’s most advanced development project. The portfolio also includes drug candidates, IBP-1016, IBP-1118, and IBP-1122. IBP-1016 isfor the treatment of gastroschisis, a life-threatening and rare condition where the child is bornwith externalized abdominal organs. IBP-1118 aims to prevent ROP (retinopathy ofprematurity), a leading cause of blindness in premature infants, while IBP-1122 aims toeliminate vancomycin-resistant enterococci (VRE), which cause antibiotic-resistant hospitalacquired infections. By developing these drugs, IBT has the opportunity to address medical needs where noavailable treatments currently exist. Publication The Report was submitted for publication, by the CEO, at 08.30 on August 25, 2023. Contact person Staffan Strömberg, CEO Maria Ekdahl, CFO Contact information Infant Bacterial Therapeutics AB (Reg. no. 556873-8586)Bryggargatan 10 111 21 Stockholm, Sweden Telephone: +46 76 219 37 38info@ibtherapeutics.com www.ibtherapeutics.com Attachment IBTQ2 2023 ENG

Phase 3Orphan DrugClinical Result

31 Jul 2023

·www.globenewswire.com

New number of shares and votes in IBT

The number of shares and votes in Infant Bacterial Therapeutics AB (publ) has changed due to the recently completed rights issue (for further information, see the company’s press release on 4 July 2023). Through the rights issue, the number of shares in IBT increased with 2,245,236 (of which 75,547 class A shares and 2,169,689 class B shares) and the number of votes increased with 2,925,159. Today, on the last trading day of the month, there are in total 13,471,420 shares (of which 453,283 class A shares and 13,018,137 class B shares) and 17,550,967 votes in IBT. About Infant Bacterial Therapeutics AB 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 (IBT B). IBT is a pharmaceutical company whose purpose is to develop and market drugs targeting diseases affecting prematurely born infants or caused by antibiotic-resistant bacteria.IBT’s main focus is on its drug candidate IBP-9414, whose development program is designed to demonstrate a reduced incidence of necrotizing enterocolitis (NEC) and whether prematurely born infants achieve improved sustained feeding tolerance (SFT) when treated with the active substance Lactobacillus reuteri, a bacterial strain naturally found in human breast milk. IBP-9414 is currently in an ongoing registration-enabling pivotal Phase III study and is the company’s most advanced development project. The portfolio also includes drug candidates, IBP-1016, IBP-1118, and IBP-1122. IBP-1016 is for the treatment of gastroschisis, a life-threatening and rare condition where the child is born with externalized abdominal organs. IBP-1118 aims to prevent ROP (retinopathy of prematurity), a leading cause of blindness in premature infants, while IBP-1122 aims to eliminate vancomycin-resistant enterococci (VRE), which cause antibiotic-resistant hospital acquired infections. By developing these drugs, IBT has the opportunity to address medical needs where no available treatments currently exist. Publication This is information that Infant Bacterial Therapeutics AB (publ) is obliged to make public pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact person set out above, on 31 July 2023, at 10:00 CEST. For additional information please contactStaffan Strömberg, CEOInfant Bacterial Therapeutics ABBryggargatan 10111 21 StockholmPhone: +46 76 219 3738info@ibtherapeutics.comwww.ibtherapeutics.com Attachment PR ENG New number shares and votes

Phase 3Qualified Infectious Disease ProductMicrobial therapy

100 Deals associated with Lactobacillus reuteri

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KEGG	Wiki	ATC	Drug Bank
-	Lactobacillus reuteri	A07FA01	DB14224

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Approved

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

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Enterocolitis, Necrotizing	Phase 3	US	Infant Bacterial Therapeutics AB	04 Jul 2019
Enterocolitis, Necrotizing	Phase 3	BG	Infant Bacterial Therapeutics AB	04 Jul 2019
Enterocolitis, Necrotizing	Phase 3	FR	Infant Bacterial Therapeutics AB	04 Jul 2019
Enterocolitis, Necrotizing	Phase 3	HU	Infant Bacterial Therapeutics AB	04 Jul 2019
Enterocolitis, Necrotizing	Phase 3	IL	Infant Bacterial Therapeutics AB	04 Jul 2019
Enterocolitis, Necrotizing	Phase 3	PL	Infant Bacterial Therapeutics AB	04 Jul 2019
Enterocolitis, Necrotizing	Phase 3	RO	Infant Bacterial Therapeutics AB	04 Jul 2019
Enterocolitis, Necrotizing	Phase 3	RS	Infant Bacterial Therapeutics AB	04 Jul 2019
Enterocolitis, Necrotizing	Phase 3	ES	Infant Bacterial Therapeutics AB	04 Jul 2019
Enterocolitis, Necrotizing	Phase 3	GB	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)	yajujcqhxs(odksvxamen) = kaaoapmdlh ctxvgjocwh (ncumfwemvg, fvoazliulz - wvpeubtxab) View more	-	24 Apr 2017
				Placebo (Placebo)	yajujcqhxs(odksvxamen) = akdvbwotyx ctxvgjocwh (ncumfwemvg, vhhddjvlzk - xcacoksqlx) View more
NCT01541046 (Pubmed \| J Postgrad Med)	Phase 2	Colic	52	Lactobacillus reuteri DSM 17938	ujrpqydiev(kuyuafrxko) = xrgdodixtu etixoumfzc (fupzhlebwp )	Positive	01 Jan 2015
				Placebo	ujrpqydiev(kuyuafrxko) = kulmmwlska etixoumfzc (fupzhlebwp )
NCT01531179 (Pubmed \| Arch Dis Child Fetal Neonatal Ed)	Phase 3	Enterocolitis, Necrotizing	400	Lactobacillus reuteri	yqcgvsncdc(fdztlgcjkl) = zqgsnnjbsd vfbsnccgze (iabtaqdbrr ) View more	-	01 Mar 2014
				Lactobacillus Reuteri (Placebo)	yqcgvsncdc(fdztlgcjkl) = wpepychfjf vfbsnccgze (iabtaqdbrr ) View more
ERS2013	Not Applicable	Asthma	112	Vitamin D(3) associated to Lactobacillus Reuteri (VD3R+)	yawkpadfhh(isvlnfuhjm) = clepqzjuge gswfxiuysg (qokailpnur, 11.8 - 26.4) View more	-	01 Sep 2013
				Vitamin D(3) without Lactobacillus Reuteri (VD3R-)	yawkpadfhh(isvlnfuhjm) = ybweardqwh gswfxiuysg (qokailpnur, 16.0 - 29.0) View more
NCT00774163 (CTgov)	Phase 1	-	45	Lactobacillus reuteri (Lr) (Lactobacillus Reuteri Group)	xxutmqmewn(befhurorzy) = crfgntlnna nkxdbjhwxm (qshdisqiux, lldjafolxb - ncgyvfbklc) View more	-	12 Jul 2013
				Placebo (Placebo Group)	xxutmqmewn(befhurorzy) = dvdievgkld nkxdbjhwxm (qshdisqiux, ynyazcwowq - xzhrkeurqu) View more
Pubmed \| J Nutr	Not Applicable	-	494	Probiotics Lactobacillus reuteri DSM 17938 (Low-lactose milk with low calcium content)	xkxocgpqev(ylqgygmknx) = dhvfcsrhlv tfiwhomwwz (htwqwcbumd, 0.01, 0.05) View more	-	01 Jul 2013
				Regular calcium with Lactobacillus casei CRL 431	fmqnalnqji(czooejvkhs) = rmczpqdflw ftibqxkslj (tjeeilvfpf, 0.001, 0.05)

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