Primary Objective: To evaluate the capacity of Lactobacillus reuteri DSM17938 to activate NOD2 receptors in preterm infants.
Secondary Objective: To analyze the impact of Lactobacillus reuteri DSM17938 on the gut microbiome of preterm infants

Start Date26 Dec 2024

Sponsor / Collaborator-

CTRI/2024/11/077444

/ Not yet recruitingNot ApplicableIIT

Does oral Lactobacillus therapy help in prevention of recurrent UTI as compared to oral antibiotic prophylaxis- A randomized controlled trial. - NIL

Start Date30 Nov 2024

Sponsor / Collaborator-

100 Clinical Results associated with Lactobacillus reuteri

100 Translational Medicine associated with Lactobacillus reuteri

100 Patents (Medical) associated with Lactobacillus reuteri

974

Literatures (Medical) associated with Lactobacillus reuteri

31 Dec 2025·Gut Microbes

Upregulation of Lactobacillus spp . in gut microbiota as a novel mechanism for environmental eustress-induced anti-pancreatic cancer effects

Article

Author: Du, Min ; Li, Huimin ; Liang, Yiyi ; Li, Xinran ; Li, Xin ; Gao, Xiang ; Cui, Jiujie ; Cong, Hui ; Huang, Yimeng ; Li, Jin ; Wang, Liwei ; Gan, Yu ; Tu, Hong ; Gao, Jian ; Li, Qian

Pancreatic ductal adenocarcinoma (PDAC) is a highly lethal malignancy with limited effective treatment options. Emerging evidence links enriched environment (EE)-induced eustress to PDAC inhibition. However, the underlying mechanisms remain unclear. In this study, we explored the role of gut microbiota in PDAC-suppressive effects of EE. We demonstrated that depletion of gut microbiota with antibiotics abolished EE-induced tumor suppression, while fecal microbiota transplantation (FMT) from EE mice significantly inhibited tumor growth in both subcutaneous and orthotopic PDAC models housed in standard environment. 16S rRNA sequencing revealed that EE enhanced gut microbiota diversity and selectively enriched probiotic Lactobacillus, particularly L. reuteri. Treatment with L. reuteri significantly suppressed PDAC tumor growth and increased natural killer (NK) cell infiltration into the tumor microenvironment. Depletion of NK cells alleviated the anti-tumor effects of L. reuteri, underscoring the essential role of NK cell-mediated immunity in anti-tumor response. Clinical analysis of PDAC patients showed that higher fecal Lactobacillus abundance correlated with improved progression-free and overall survival, further supporting the therapeutic potential of L. reuteri in PDAC. Overall, this study identifies gut microbiota as a systemic regulator of PDAC under psychological stress. Supplementation of psychobiotic Lactobacillus may offer a novel therapeutic strategy for PDAC.

31 Dec 2025·Gut Microbes

Reutericyclin, a specialized metabolite of Limosilactobacillus reuteri , mitigates risperidone-induced weight gain in mice

Article

Author: Kindel, Tammy L ; Smith, Brian C ; Grobe, Justin L ; Hadiono, Matthew A ; Kazen, Alexis B ; Keyes, Robert F ; Aboulalazm, Fatima A ; Kellogg, Stephanie L ; Lozada-Fernandez, Valery ; deLeon, Orlando ; Saravia, Fatima L ; Kirby, John R ; Müller, Susanne

The role of xenobiotic disruption of microbiota, corresponding dysbiosis, and potential links to host metabolic diseases are of critical importance. In this study, we used a widely prescribed antipsychotic drug, risperidone, known to influence weight gain in humans, to induce weight gain in C57BL/6J female mice. We hypothesized that microbes essential for maintaining gut homeostasis and energy balance would be depleted following treatment with risperidone, leading to enhanced weight gain relative to controls. Thus, we performed metagenomic analyses on stool samples to identify microbes that were excluded in risperidone-treated animals but remained present in controls. We identified multiple taxa including Limosilactobacillus reuteri as a candidate for further study. Oral supplementation with L. reuteri protected against risperidone-induced weight gain (RIWG) and was dependent on cellular production of a specialized metabolite, reutericyclin. Further, synthetic reutericyclin was sufficient to mitigate RIWG. Both synthetic reutericyclin and L. reuteri restored energy balance in the presence of risperidone to mitigate excess weight gain and induce shifts in the microbiome associated with leanness. In total, our results identify reutericyclin production by L. reuteri as a potential probiotic to restore energy balance induced by risperidone and to promote leanness.

01 May 2025·POULTRY SCIENCE

Lactobacillus reuteri alleviates diquat induced hepatic impairment and mitochondrial dysfunction via activation of the Nrf2 antioxidant system and suppression of NF-κB inflammatory response

Article

Author: Hu, Zhaoying ; Lv, Yujie ; Shen, Xinyu ; Lin, Gang ; Wu, Lianchi ; Huang, Weichen ; Liu, Bing ; Zhan, Shenao ; Yu, Dongyou ; Ge, Chaoyue

Accumulating evidence has shown that elevated oxidative stress and inflammatory response leads to hepatic impairment and dysfunction of hens during the aging process. This study was conducted to investigate the potential regulatory mechanisms of Lactobacillus reuteri (L. reuteri) in alleviating hepatic oxidative stress and dysfunction induced by diquat (DQ) exposure. A total of 480 48-wk-old Jingbai hens were randomly assigned to 4 groups: control group (Con), L. reuteri group (L.R), diquat-challenged group (DQ), and L. reuteri protective group (L.R+DQ). The results demonstrated that DQ exposure induced oxidative damages and lipid metabolism disorders manifested as the elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) activities, triglyceride (TC) contents in serum and lipid accumulation in liver. L. reuteri supplementation alleviated DQ-induced liver oxidative injury, reflected by repairing the morphology of liver and decreasing the AST and ALT activities in serum. L. reuteri decreased the hepatic malonaldehyde (MDA) accumulation and enhanced the total antioxidant capacity (T-AOC), glutathione peroxidase (GSH-Px), and superoxide dismutase (SOD) activities in liver through regulating the nuclear factor erythroid 2-related factor 2 (Nrf2) and hemeoxygenase-1 (HO-1) mediated antioxidant system. In addition, L. reuteri curtailed reactive oxygen species (ROS) production and mitigated the depletion of membrane potential and thus recovering mitochondrial function disturbed by DQ challenge. Moreover, L. reuteri inhibited hepatic toll-like receptor 4 (TLR4)/myeloid differentiation factor 88 (MyD88)/nuclear factor-kappa B (NF-κB) pathway activation, downregulated the pro-inflammatory-response-related gene expressions (IL-1β, TNF-α, and IL-6) and the phosphorylation levels of IκBα, and p65 in liver and thus reducing hepatic inflammatory response and apoptosis. Overall, the findings indicate that L. reuteri provides significant protection against oxidative stress, mitochondrial impairment, inflammatory response and apoptosis caused by DQ in laying hens, and highlight its potential as a therapeutic probiotic for alleviating oxidative stress and mitochondrial dysfunction to prolong the health of aging poultry.

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	India	BioGaia AB	30 Apr 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Enterocolitis, Necrotizing	Phase 3	United States	Infant Bacterial Therapeutics AB	04 Jul 2019
Enterocolitis, Necrotizing	Phase 3	Bulgaria	Infant Bacterial Therapeutics AB	04 Jul 2019
Enterocolitis, Necrotizing	Phase 3	France	Infant Bacterial Therapeutics AB	04 Jul 2019
Enterocolitis, Necrotizing	Phase 3	Hungary	Infant Bacterial Therapeutics AB	04 Jul 2019
Enterocolitis, Necrotizing	Phase 3	Israel	Infant Bacterial Therapeutics AB	04 Jul 2019
Enterocolitis, Necrotizing	Phase 3	Poland	Infant Bacterial Therapeutics AB	04 Jul 2019
Enterocolitis, Necrotizing	Phase 3	Romania	Infant Bacterial Therapeutics AB	04 Jul 2019
Enterocolitis, Necrotizing	Phase 3	Serbia	Infant Bacterial Therapeutics AB	04 Jul 2019
Enterocolitis, Necrotizing	Phase 3	Spain	Infant Bacterial Therapeutics AB	04 Jul 2019
Enterocolitis, Necrotizing	Phase 3	United Kingdom	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	mdjkunhqnp(mejeiypsmh) = avuyjikvcu ctinaxmrsv (qqhvwermnl ) View more	Positive	14 Nov 2024
				Placebo	mdjkunhqnp(mejeiypsmh) = bwbemnjpxw ctinaxmrsv (qqhvwermnl ) View more
NCT03978000 (Company_Website) Manual	Phase 3	Enterocolitis, Necrotizing	2,153	IBP-9414	dugbiaudtx(tygfmvhmpq) = xmtpzjkika yskbpzjgul (wdnditarwx ) View more	Negative	30 Aug 2024
				Placebo	dugbiaudtx(tygfmvhmpq) = fsqisxfhkg yskbpzjgul (wdnditarwx ) View more
NCT05701683 (Pubmed \| Helicobacter)	Phase 4	Helicobacter pylori infection	195	non-viable Lactobacillus reuteri (Placebo)	xodkvritul(vpkrzprbnk) = shxezrspws mshqoszfuz (tibjnmodcy ) View more	Negative	10 Oct 2021
NCT02723344 (Pubmed \| Front Neurol)	Phase 1	Stress Disorders, Post-Traumatic C-reactive protein	75	Immunomodulatory Probiotic Intervention	rddidwuitq(sqbqtllbgn): P-Value = 0.006	-	20 Oct 2020
				Immunomodulatory Probiotic Intervention
NCT01541046 (Pubmed \| J Pediatr)	Phase 2	Colic	52	Lactobacillus reuteri DSM 17938	wujgbtwckp(repjapkpkw) = jpgyqfngxn esbmywwjkb (oseebxljoz )	Positive	01 Jan 2015
				Placebo	wujgbtwckp(repjapkpkw) = seaqmqibgp esbmywwjkb (oseebxljoz )
ERS2013	Not Applicable	Asthma	112	Vitamin D(3) associated to Lactobacillus Reuteri (VD3R+)	hyymvqpstb(nrbgpnbrqi) = yaampbmuoa qodkypgxqh (kiadnjslqf, 11.8 - 26.4) View more	-	01 Sep 2013
				Vitamin D(3) without Lactobacillus Reuteri (VD3R-)	hyymvqpstb(nrbgpnbrqi) = xracavgbog qodkypgxqh (kiadnjslqf, 16.0 - 29.0) View more

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