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Designed bacterial compositions

A composition and bacterial technology, applied in the direction of bacteria, drug combinations, antibacterial drugs, etc., can solve problems such as difficulties and reduce complete treatment compliance

Pending Publication Date: 2019-04-19
SERES HEALTH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The FMT method also introduces the risk of infection by pathogenic organisms, including viruses, bacteria, fungi and protists in the source material
In addition, there may be issues related to the stability and storage of donated feces, such as those related to the survival of bacterial species
Some treatments using fecal bacteria delivered in capsules require patients to take a large number of capsules, which can be difficult for people with GI disorders and can reduce adherence to complete treatment

Method used

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  • Designed bacterial compositions
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0126] Example 1: Murine Model of Clostridium difficile Infection (CDI)

[0127] The efficacy of the test composition was studied using a mouse challenge model of CDI (Chen et al., 2008, Gastroenterology, 135: 1984-1992). A mouse CDI model was used to demonstrate prevention of infection. In this model, mice are pretreated with antibiotics to create dysbiosis in the gut, which increases CDI susceptibility. When challenged with orally administered C. difficile spores, mice exhibited symptoms of CDI, including weight loss, diarrhea, and lethargy, with a disease peak 2-3 days after C. difficile inoculation. Infection can be fatal, and death occurs at the peak of the disease. In mice that survived infection, symptoms resolved mainly by day 6 post-inoculation. Animals were housed in a bioBubble clean room or equivalent facility for the duration of the experiment.

[0128] Briefly, on days -14 to -6, animals (female C57BL / 6 mice, 9-10 weeks old) received an antibiotic cocktail ...

Embodiment 2

[0130] Example 2: Test Items

[0131] Applicants have tested about 100 different DBCs. In one example of such an experiment, the murine model described in Example 1 was used to evaluate the efficacy of various orally administered microbial spore preparations for the treatment / prevention of Clostridium difficile infection (CDI). Nine compositions were tested at estimated doses ranging from 1e2 to 1e5 for each individual species in the composition. Estimates of bacterial numbers were based on spore colony forming unit (SCFU) assays (ie, the number of spore-derived colonies grown on plates from stock solutions). Methods for performing such assays are known in the art and generally involve germination agents suitable for the growth of the species. Table 3 provides some of the compositions tested (supra). Negative controls included PBS alone as treatment and naive animals (not infected with C. difficile). Positive controls included treatment with a slurry of healthy human fec...

Embodiment 3A

[0136] Example 3A: Carbon Utilization

[0137]Antibiotics are known to disrupt the gut microflora, leading to loss of colonization resistance and setting the stage for infection by pathogens, including Clostridium difficile (reviewed in Keeney et al., 2014 Ann Rev Microbiol, 2014 6 2. doi:10.1146 / annurev-micro-091313-103456). The contribution of nutrient competition to C. difficile colonization resistance was suggested in earlier experiments in a continuous flow model, where glucose, N-acetylglucosamine, and sialic acid (N-acetylneuraminic acid) were identified as C. difficile carbon sources are of limited availability due to catabolism by intestinal organisms (Wilson and Perini, 1988, Infection and Immunity, 56:2610-14). More recently, sialic acid utilization by C. difficile was associated with higher C. difficile levels in a mouse model (Ng et al., 2013 Nature advance online publication (1 September 2013). doi: 10.1038 / nature12503). Thus, a useful feature of a DBC is a ...

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Abstract

Compositions and methods of treating a gastrointestinal dysbiosis using a limited number of defined bacterial species are provided.

Description

technical field [0001] Disclosed herein are bacterial compositions useful for treating dysbiosis, eg, in humans. Background technique [0002] Dysbiosis is associated with many diseases, including infections such as Clostridium difficile and drug-resistant enterococci, and metabolic diseases such as diabetes. Approaches to treating dysbiosis-related conditions include fecal microbiome transplantation (FMT), which provides microbes to the gastrointestinal tract (GI). However, fecal transplantation presents a number of issues, including those related to safety and delivery methods such as naso-duodenal, transcolonoscopy-based or enema-based approaches, which often require an in-clinic procedure and may introduce adverse event. Treatment using FMT has the potential for inherent inconsistency due to the variability among individuals donating feces for transplantation. The FMT method also introduces the risk of infection by pathogenic organisms, including viruses, bacteria, fu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/741A61K35/742A61P1/00A61P31/04
CPCA61K35/741A61K35/742A61P31/04A61P1/00C12N1/20
Inventor J·巴顿D·库克M·海恩M-J·L·麦肯齐K·利科弗斯凯A·马蒂奈兹G·麦肯齐M·南达库马尔M·乌里克J·沃特曼
Owner SERES HEALTH
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