Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571097
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Levofloxacin in the Treatment of Chronic Functional Constipation Associated With PIBPeristaltic Contraction-Inhibiting Bacterium Infection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Levofloxacin in the Treatment of Chronic Functional Constipation Associated With PIB Infection A Multi-center Exploratory Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Constipation a prevalent clinical condition significantly impacts patients quality of life yet relevant clinical trial technical guidelines have yet to be issued domestically This disease encompasses various classifications based on etiology pathology and pathophysiological characteristics Slow transit constipation STC specifically arises from colonic motility disorders and is recognized as a neuromuscular colonopathy Currently limited therapeutic options are available for patients with refractory STC rendering it a common ailment associated with substantial disease burden and uncertain etiology Consequently identifying the cause and developing effective targeted and safe treatment strategies is of paramount importance
Our research team has made a groundbreaking international discovery revealing that STC is caused by infection with a novel Shigella-like bacterium termed the peristaltic contraction-inhibiting bacterium PIB which secretes docosapentaenoic acid DPA an unsaturated fatty acid The pathogenic mechanism involves inhibition of intestinal peristalsis subsequently slowing colonic transit Preliminary epidemiological studies confirm the exclusive presence of PIB in feces from patients with intractable constipation whereas it is virtually absent in healthy individuals Notably consumption of high-dose DPA does not affect colonic transit or induce constipation however intracolonic administration does
In response to PIB-induced STC our team screened a range of antibiotics and identified two primary classes with potent antibacterial effects against PIB fluoroquinolones and carbapenems Both classes exhibit strong inhibitory activity against PIB suggesting their potential use in chronic constipation treatment Levofloxacin a quinolone antibiotic possesses broad-spectrum and potent antibacterial properties effective in treating intestinal and urinary tract infections Given that PIB has been confirmed as a novel Shigella-like species and quinolones are established as the first-line antibiotics for Shigella infections levofloxacins efficacy against PIB was anticipated Preliminary studies have validated levofloxacins ability to inhibit PIB growth thereby alleviating PIB-induced refractory constipation through sensitivity testing
The primary objective of this study is to utilize levofloxacin to suppress PIB thereby achieving the relief of chronic functional constipation
Our research team has made a groundbreaking international discovery revealing that STC is caused by infection with a novel Shigella-like bacterium termed the peristaltic contraction-inhibiting bacterium PIB which secretes docosapentaenoic acid DPA an unsaturated fatty acid The pathogenic mechanism involves inhibition of intestinal peristalsis subsequently slowing colonic transit Preliminary epidemiological studies confirm the exclusive presence of PIB in feces from patients with intractable constipation whereas it is virtually absent in healthy individuals Notably consumption of high-dose DPA does not affect colonic transit or induce constipation however intracolonic administration does
In response to PIB-induced STC our team screened a range of antibiotics and identified two primary classes with potent antibacterial effects against PIB fluoroquinolones and carbapenems Both classes exhibit strong inhibitory activity against PIB suggesting their potential use in chronic constipation treatment Levofloxacin a quinolone antibiotic possesses broad-spectrum and potent antibacterial properties effective in treating intestinal and urinary tract infections Given that PIB has been confirmed as a novel Shigella-like species and quinolones are established as the first-line antibiotics for Shigella infections levofloxacins efficacy against PIB was anticipated Preliminary studies have validated levofloxacins ability to inhibit PIB growth thereby alleviating PIB-induced refractory constipation through sensitivity testing
The primary objective of this study is to utilize levofloxacin to suppress PIB thereby achieving the relief of chronic functional constipation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None