Compositions and methods for treating inflammatory bowel disease
Inventors
Britton, Graham J. • Faith, Jeremiah J.
Assignees
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Publication Number
US-12642819-B2
Publication Date
2026-06-02
Expiration Date
Abstract
The present invention provides methods of diagnosing, treating, and monitoring the progression of inflammatory bowel disease in a subject, including, for example, by monitoring RORγt+Th or RORγt+Treg cell levels and treating the subject accordingly.
Core Innovation
The document describes diagnosing, treating, and monitoring inflammatory bowel disease (IBD) in a subject by measuring immune biomarkers associated with gut microbiota. The biomarkers include RORγt+ Th (Th17 lineage) and RORγt+ Treg, including FoxP3+ and RORγt+ Treg, and disease presence, prognosis, and treatment response are correlated with biomarker levels, including a RORγt+ Treg/Th ratio.
The disclosed findings indicate that IBD-associated microbiotas increase induction of RORγt+ Th while total FoxP3+ Treg is not different. In contrast, healthy donor microbiotas preferentially enhance RORγt+ Treg, and the homeostatic RORγt+ Th and the inversely related RORγt+ Treg proportions in gut predict colitis severity and donor health, including ROC/AUC.
The document also describes treating inflammatory bowel disease by administering therapeutic compositions comprising a bacterial community consisting essentially of specified strains with sequence identifier traceability (SEQ ID NO). Therapeutic improvement is reported when RORγt+Treg-inducing cultured microbiota cocktails are administered, and the document includes exemplary effective bacterial communities including a community listing of specific taxa.
Claims Coverage
The partial content includes two independent claims. Both claims are centered on treating, including for inflammatory bowel disease and via GI administration, using a therapeutic composition comprising a defined bacterial community consisting essentially of specified strains identified by SEQ ID NOs, and one claim additionally requires stimulation of RORγt+ Treg cell production.
Treating inflammatory bowel disease with a defined multi-strain bacterial community
A method of treating inflammatory bowel disease in a subject by administering a therapeutic composition comprising a bacterial community consisting essentially of specified strains: Bacteroides dorei (SEQ ID NO: 4), Bacteroides fragilis (SEQ ID NO: 5), Bacteroides ovatus (SEQ ID NO: 7), Bacteroides thetaiotaomicron (SEQ ID NO: 10), Bifidobacterium adolescentis (SEQ ID NO: 17), first Bifidobacterium longum (SEQ ID NO: 23), second Bifidobacterium longum (SEQ ID NO: 24), Bifidobacterium pseudocatenulatum (SEQ ID NO: 27), Butyricicoccus sp. (SEQ ID NO: 29), Clostridium sp. (SEQ ID NO: 34), Collinsella aerofaciens (SEQ ID NO: 36), Escherichia coli (SEQ ID NO: 43), Lactobacillus casei (SEQ ID NO: 47), Parabacteroides distasonis (SEQ ID NO: 50), and Ruminococcus torques (SEQ ID NO: 55).
Stimulating RORγt+ Treg cell production using the defined bacterial community
A method of treating a disease in a subject by administering a therapeutic composition that stimulates RORγt+ Treg cell production, wherein the therapeutic composition comprises a bacterial community consisting essentially of specified strains with the same SEQ ID NO assignments for Bacteroides dorei, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bifidobacterium adolescentis, two Bifidobacterium longum strains, Bifidobacterium pseudocatenulatum, Butyricicoccus sp., Clostridium sp., Collinsella aerofaciens, Escherichia coli, Lactobacillus casei, Parabacteroides distasonis, and Ruminococcus torques.
Across the independent claims, the core claimed inventive coverage is therapeutic treatment by administering a therapeutic composition containing a bacterial community consisting essentially of multiple specified strains identified by SEQ ID NOs, and, in the second claim, that composition is required to stimulate RORγt+ Treg cell production.
Stated Advantages
Improvement in inflammatory bowel disease is reported when RORγt+Treg-inducing cultured microbiota cocktails are administered.
Documented Applications
Diagnosing, treating, and monitoring inflammatory bowel disease (IBD) by correlating RORγt+ Th and RORγt+ Treg biomarker measurements, including RORγt+ Treg/Th ratios, with disease presence, prognosis, and treatment response.
Treating inflammatory bowel disease in a subject by administering a therapeutic composition comprising a bacterial community consisting essentially of specified strains (SEQ ID NO traceability).
Treating a disease in a subject by administering a therapeutic composition that stimulates RORγt+ Treg cell production, using the same defined bacterial community.
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