An interventional study of Levofloxacin in Constipation, sponsored by Haifeng Lan. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-26.
Sponsored by Haifeng Lan · Not applicable, Interventional, and Treatment
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, levofloxacin's efficacy against PIB was anticipated. Preliminary studies have validated levofloxacin's 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.
1,041 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's planned enrollment of 50 is below the median of 78 across 867 interventional studies indexed under Constipation.
Browse Constipation studies →Haifeng Lan is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Participants must meet all of the following criteria to enter the trial.
Exclusion Criteria:
Exclusion criteria: Subjects must exclude all of the following conditions to enter the study.
Levofloxacin: 0.5g(500mg)/day for 2 weeks
Drug: Levofloxacin
0.5g/day for 2 weeks
Total effective rate of levofloxacin in the treatment of chronic functional constipation.
Obvious effect: no defecation difficulty, the number of spontaneous defecation ≥3 times/week (no effort and time consuming when defecating, no feeling of inadequate defecation, normal stool characteristics, etc.); Effective: the difficulty of defecation is improved than before, and the number of autonomous defecation is not less than 3 times/week (one of the time-consuming and laborious defecation or improper defecation or abnormal stool characteristics occurs during defecation);Ineffective: The difficulty of defecation is no better than before, and the number of spontaneous defecation is less than 3 times/week.Total effective rate = (significant efficiency + effective rate) Number of cases/total number of cases ×100%.
Time frame: 6 months
PIB concentration (DPA content of docosapentaenoic acid)
PIB concentration ( DPA content in intestinal stool)
Time frame: 6 months
Proportion of patients with first defecation
Proportion of patients with complete spontaneous defecation within 24-48 hours after receiving the first dose
Time frame: 24-48 hours
Time of first defecation
The time of patients with complete spontaneous defecation within 24-48 hours after receiving the first dose.
Time frame: 24-48 hours
Number of frequency of use of rescue drugs and other Other defecation medications per week
Number of frequency of use of rescue drugs and other Other defecation medications per week
Time frame: 6 months
PAC-SYM
PAC-SYM（Patient Assessment of Constipation symptom）
Time frame: 6 months
PAC-QoL scale
PAC-Qol (Quality of life scale）
Time frame: 6 months
Bristol scale
Bristol (stool property)
Time frame: 6 months
The incidence of serious adverse events
intestinal obstruction, hematochezia, elevated indicators of serious infection, severe bloating, diarrhea, etc.
Time frame: 6 months
Patient satisfaction with treatment survey
Satisfaction degree of patients with levofloxacin treatment of constipation symptoms
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Haifeng Lan