Compositions and methods for treating inflammatory bowel disease and fusobacteria-caused or related diseases and conditions

An inflammatory bowel disease, Fusobacterium technology, applied in the fields of medicine and gastroenterology, pharmacology and microbiology, can solve the problem of placebo effect differentiation

Pending Publication Date: 2021-01-01
托马斯·朱利叶斯·波洛迪
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This observation has prompted the use of antibiotics to induce remission in IBD; however, despite numerous clinical trials, the results of some antibiotics appear to induce remission in IBD, and the majority of clinical trials have had poor results, with placebo effects barely distinguishable from antibiotic-administered groups (see eg Gionchetti P. et al. 1999; Perencevich, M., 2006)

Method used

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  • Compositions and methods for treating inflammatory bowel disease and fusobacteria-caused or related diseases and conditions
  • Compositions and methods for treating inflammatory bowel disease and fusobacteria-caused or related diseases and conditions
  • Compositions and methods for treating inflammatory bowel disease and fusobacteria-caused or related diseases and conditions

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0367] A 41-year-old female patient with a 12-year history of ulcerative colitis presented with 4-15 daily diarrheas and 2-3 nightly diarrheas. She had been treated with anti-inflammatory drugs including mesalamine, azathioprine and prednisone, and these achieved only transient responses. She also suffers from occasional bouts of urinary urgency and incontinence. Her initial colonoscopy revealed pancolitis.

[0368] She was started on secnidazole (400 mg three times daily) and rifampicin (increased from 150 mg twice daily to 300 mg twice daily after four weeks) and doxycycline (50 mg twice daily).

[0369] Over the next 6 to 8 weeks, the frequency of frequent movements slowly decreased to 3-6 times a day, bleeding was no longer seen and urgency had greatly improved. When the colonoscopy was repeated, she then continued on the same regimen for another six months. The aforementioned pancolitis is now greatly improved with almost complete healing of the mucosa. Biopsies showe...

example 2

[0371] A 42-year-old male patient with a 4-year history of Crohn's disease presented with a Crohn's disease activity index (CDAI) score of 550, 7-10 liquid stools per day, abdominal pain, inflammation, and deep ulcers microscopically. The patient was previously exposed to anti-TNF therapy, which was only transiently effective.

[0372] The patient was started on a combination of rifaximin (500 mg twice a day), tinidazole (500 mg twice a day) and nitazoxanide (500 mg twice a day). Each drug dose was increased by 500 mg after 2 weeks, with rifaximin slowly increasing to a final dose of 1.5 g twice a day (total of 3 g per day).

[0373] After 4 weeks, patients reported a significant reduction in liquid stools and abdominal pain. He observed a colonoscopy at 5 months, which showed excellent ulcer healing and significant improvement in inflammation. After another 4 months of treatment, the patient reported a more normal bowel movement frequency, roughly 3 soft stools a day, with ...

example 3

[0375] A 32-year-old male with long-standing ulcerative colitis (UC) showed on examination an extension of 45 cm from the anus because his initial treatment with immunomodulators failed to control his UC. A colonoscopy was performed on him and the inflammatory process was found to converge, starting at the anus and reaching approximately 40 cm. Collect cultures and biopsies. He has been treated with azathioprine and mesalamine plus steroids, but his Humira treatment has failed.

[0376] He started fosfomycin (1 g bid) in combination with doxycycline (50 mg bid) and metronidazole (400 mg bid) for 4 weeks.

[0377] His bloody stool frequency improved significantly after 2 weeks and his stools formed by 4 weeks of treatment. Bleeding stops after about a year of adhering to previous medication. At her 8-week colonoscopy, the microspots were still inflamed, but were generally marked as improved. With ongoing additional fecal microbiota transplant capsule treatment, the colon be...

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Abstract

Provided herein are pharmaceutical compositions, therapeutic combinations, devices and methods for treating, ameliorating, reversing, causing the remission of, and / or preventing (acting as a prophylaxis, or preventing the initiation of) an inflammatory bowel disorder (IBD) or inflammatory bowel disease (IBD), Ulcerative Colitis; Crohn's disease; J-pouch; fistulising Crohn's disease; a Colitis which can be microscopic, lymphocytic or collagenous; an eosinophilic colitis; indeterminate colitis; idiopathic colitis; diverticulosis and diverticulitis; relapsing diverticulitis; constipation associated inflammatory bowel disease and / or small intestinal bacterial overgrowth; Irritable Bowel Syndrome (IBS) with or without diarrhoea, constipation or pain predominant IBS; periodontitis; rheumatoid arthritis; respiratory infections, appendicitis, vascular disorders such as thrombophlebitis; bacteremia; osteomyelitis; septic shock; Alzheimer's disease; Lemierre syndrome (postanginal sepsis); colonic polyps or adenomas (optionally hyperplastic, adenomatous or serrated adenomas) or preventing the growth of colonic polyps or adenomas, bowl cancer, or metastases (optionally preventing the initiation or promotion of bowl cancer or metastasis); pharyngitis; otitis; sinusitis; and any disease, symptom or condition caused or exacerbated by a Fusobacteria (optionally, a F. nucleatum or F. varium) infection. In alternative embodiments, pharmaceutical compositions comprise rifaximin alone or in combination with other antibiotics or drugs.

Description

technical field [0001] The present invention relates generally to medicine and gastroenterology, pharmacology and microbiology. In alternative embodiments, pharmaceutical compositions, therapeutic combinations, devices and methods are provided for treating, ameliorating, reversing (e.g. causing or inducing remission) and / or preventing (serving as prophylaxis) the following diseases: inflammatory bowel disease or inflammatory bowel disease Bowel disorders (both collectively referred to as IBD), ulcerative colitis; Crohn's disease; J-pouch; fistulating Crohn's disease; colitis which can be microscopic, lymphocytic, or collagenous; Eosinophilic colitis; indeterminate colitis; idiopathic colitis; diverticular disease and diverticulitis; recurrent diverticulitis; constipation-associated inflammatory bowel disease and / or small bowel bacterial overgrowth; irritable bowel syndrome (IBS) , with or without IBS with predominant diarrhea, constipation, or pain; periodontitis; rheumatoid ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/437A61K31/496A61K31/454A61K31/495A61P31/00
CPCA61K31/4164A61K31/496A61K31/65A61K31/437A61K31/426A61K31/665A61P1/00A61K2300/00A61P31/00A61K45/06Y02A50/30A23L33/10A61P1/04A23V2002/00A61K9/0056A61K47/32A61K47/36A61K47/46
Inventor 托马斯·朱利叶斯·波洛迪
Owner 托马斯·朱利叶斯·波洛迪
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