Levofloxacin in the Treatment of Chronic Functional Constipation Associated With PIB(Peristaltic Contraction-Inhibiting Bacterium) Infection

NCT06571097 | Recruiting

• 1 other identifier: DZQH-KYLL-24-20
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Constipation

Keywords

Levofloxacin; PIB; Peristaltic Contraction-Inhibiting Bacterium; constipation

Outcome Measures

Primary Outcomes (1)

• 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%.

  6 months

Secondary Outcomes (9)

• PIB concentration (DPA content of docosapentaenoic acid)

  6 months

• Proportion of patients with first defecation

  24-48 hours

• Time of first defecation

  24-48 hours

• Number of frequency of use of rescue drugs and other Other defecation medications per week

  6 months

• PAC-SYM

  6 months

Study Arms (1)

Levofloxacin

EXPERIMENTAL

Levofloxacin: 0.5g(500mg)/day for 2 weeks

Drug: Levofloxacin

Interventions

Levofloxacin DRUG

0.5g/day for 2 weeks

Levofloxacin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria to enter the trial.
• Signed written informed consent;
• Age 18-70;
• Diagnosed chronic functional constipation according to Rome III or IV criteria, and infected with PIB;
• Patients who have not taken other types of antibiotics in the past 1 month;
• Bowel organic lesions (tumors and severe inflammatory lesions, etc.) were excluded by colonoscopy in the past 2 years.
• The subjects could follow the follow-up plan, objectively describe the symptoms, and cooperate with the completion of the scale; 7）Agree to maintain similar diet and activity levels from the screening visit to the end of the study;

You may not qualify if:

• Pregnant and lactating women;
• Patients with drug-induced constipation, including constipation induced by opioids and antidepressants;
• During the study period, changes in lifestyle and dietary habits are not recommended in principle;
• Patients with diseases that affect the conduct or results of the study, such as mental illness, serious cardiopulmonary, liver and kidney diseases, history of gastrointestinal surgery, epilepsy, etc.
• Those who cannot take samples and complete inspection items as required;
• Allergic to levofloxacin; 7）Other researchers found it inappropriate to participate in the project for clinical manifestations or diseases.

Sponsors & Collaborators

• Haifeng Lan: lead

Study Sites (1)

Levofloxacin in the Treatment of Chronic Functional Constipation Associated With PIB Infection: A Multi-center, Exploratory Clinical Study

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ji Xuan

CONTACT

02580864222; helio0009@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: student

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 26, 2024
• Study Start: July 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)