IP Library Granted Patent US 11,497,780
Granted Patent B2
US 11,497,780 · App. 16/820,463 · Granted Nov 15, 2022

Prebiotic formulations

Inventors: Steven D. Goodman (Hilliard, OH); Lauren O. Bakaletz (Hilliard, OH); Michael Bailey (Columbus, OH); Gail Besner (Columbus, OH)
Assignees: Research Institute at Nationwide Children's Hospital; Ohio State Innovation Foundation
A61K35/747A01N63/20A01N63/22A01N63/23A01N63/27A23L33/135A23L33/195A61K9/0031A61K9/1647A61K9/1652A61K9/1658A61K9/50A61K35/741A61K47/10A61K47/22A23V2002/00A23V2200/3202A23V2200/3204
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Quick Facts
Patent No.
US 11,497,780
App. No.
16/820,463
Granted
Nov 15, 2022
Kind
B2
Abstract

Provided herein are compositions comprising a biocompatible microsphere, a biofilm-generating probiotic bacterium, a prebiotic, and/or a prebiofilmic. Methods for preparing and formulating the compositions and methods for treating or preventing a disease using the compositions are also provided.

Claims (14)

1. A composition comprising:

a microsphere comprising dextran cross-linked with epichlorohydrin;

a prebiotic; and

a strain of Lactobacillus reuteri (“ L. reuteri ”) that expresses glucosyltransferase (GTF) protein, wherein the prebiotic comprises an effective amount of a nutritional supplementation for the L. reuteri strain to support the formation of a biofilm.

2. The composition of claim 1 , wherein the strain of L. reuteri is adhered to the microsphere.

3. The composition of claim 1 , wherein the strain of L. reuteri is selected from the group consisting of: ATCC 23272, L. reuteri strain 100-23, ATCC PTA 6475, ATCC 55730, DSM 17938 and combination(s) thereof.

4. The composition of claim 1 , wherein the prebiotic comprises a water-soluble carbohydrate, wherein the water-soluble carbohydrate comprises one or more of inulin, oligofructose, fructo-oligosaccharide, galacto-oligosaccharide, glucose, starch, maltose, maltodextrins, polydextrose, amylose, sucrose, fructose, lactose, isomaltulose, polyols, glycerol, carbonate, thiamine, choline, histidine, trehalose, nitrogen, sodium nitrate, ammonium nitrate, phosphorus, phosphate salts, hydroxyapatite, potassium, potash, sulfur, homopolysaccharide, heteropolysaccharide, cellulose, chitin, vitamins, or a combination thereof.

5. The composition of claim 4 , wherein the water-soluble carbohydrate is maltose and/or sucrose.

6. The composition of claim 1 , further comprising a pharmaceutically acceptable carrier or a biocompatible scaffold.

7. The composition of claim 1 , wherein the strain of L. reuteri provides one or more of supporting anti-bacterial immunity, correcting dysbiosis, enhancing or supporting the gastrointestinal barrier, supporting or enhancing gastrointestinal motility, localized release of antibiotic compositions, or antagonizing disease-related bacterial infections.

8. A formulation comprising the composition of claim 1 , wherein the composition is formulated in a dosage form selected from the group consisting of: suppository, within a biocompatible scaffold, powder, liquid, capsule, chewable tablet, swallowable tablet, buccal tablet, troche, lozenge, soft chew, solution, suspension, spray, tincture, decoction, infusion, and combinations thereof.

9. A method of treating a disease selected from the group consisting of inflammatory bowel disease (IBD), colitis, enteric infectious disease, necrotizing enterocolitis (NEC), infection-induced colitis, traveler's diarrhea, and psychological disorders in a subject in need thereof, comprising administering to the subject an effective amount of the composition of claim 1 .

10. A method of preparing the composition of claim 1 comprising admixing a microsphere comprising dextran cross-linked with epichlorohydrin with [a biofilm-generating probiotic bacterium] the strain of L. reuteri , and a prebiotic.

11. The method of claim 10 , wherein the [biofilm-generating probiotic bacterium is selected from the group consisting of:] strain of L. reuteri is selected from the group consisting of: ATCC 23272, L. reuteri strain 100-23, ATCC PTA 6475, ATCC 55730, DSM 17938 [ L. acidophilus, L. crispatus, L. gasseri, L. delbrueckii, L. salivarius, L. casei, L. paracasei, L. plantarum, L. rhamnosus, L. reuteri, L. brevis, L. buchneri, L. fermentum, L. rhamnosus, B. adolescentis, B. angulation, B. bifidum, B. breve, B. catenulatum, B. infantis, B. lactis, B. longum, B. pseudocatenulatum, S. thermophiles, Pseudomonas fluorescens, P. protegens, P. brassicacearum, P. aeruginosa, Azospirillum brabrasilense, A. lipferum, A. halopraeferens, A. irakense, Acetobacter diazotrophicus, Herbaspirillum seropedicae, Bacillus subtilis, Pseudomonas stutzeri, fluorescens, P. putida, P. cepacian, P. vesicularis, P. paucimobilis, Bacillus cereus, B. thuringiensis, B. sphaericus, Shewanella oneidensis, Geobacter bemidjiensis, G. metallireducens, G. sulfurreducens, G. uraniireducens, G. lovleyi, Serratia marcescens, Desulfovibrio vulgaris, D. desulfuricans, Dechloromonas aromatic, Deinococcus radiodurans, Methylibium petroleiphilum, Alcanivorax borkumensis, Archaeglobus fulgidus, Haloferax sp., Halobacterium sp.,] and combination(s) [combinations] thereof.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 13, 2021
From: GOODMAN, STEVEN D.; BAKALETZ, LAUREN O.; BAILEY, MICHAEL; BESNER, GAIL
To: RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL
Reel/Frame 058375/0952 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 13, 2021
From: RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL
To: OHIO STATE INNOVATION FOUNDATION
Reel/Frame 058376/0022 →
Continuity (6)
Continuation 15649352 · Jul 13, 2017
Continuation In Part 15257673 · Sep 6, 2016
Continuation PCTUS2015019059 · Mar 5, 2015
Provisional Application 62477382 · Mar 27, 2017
Provisional Application 61949058 · Mar 6, 2014
Related Publication 20210100854A1 · Apr 8, 2021
Cited By (4)
US 12,221,472 US 12,239,763 US 12,365,710 US 12,419,944