Using Levofloxacin to treat chronic constipation caused by a specific bacterial infection

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

This study is testing if the antibiotic Levofloxacin can help adults with chronic constipation caused by a specific bacterial infection feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06571097 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Levofloxacin in treating chronic functional constipation associated with an infection from a novel bacterium known as PIB. The study aims to address the significant burden of slow transit constipation (STC), which is linked to colonic motility disorders and has limited treatment options. Participants will be adults aged 18-70 diagnosed with chronic constipation and confirmed PIB infection, who have not used other antibiotics recently. The trial will assess the safety and efficacy of Levofloxacin in alleviating symptoms of constipation caused by this bacterial infection.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with chronic functional constipation and confirmed PIB infection.

Not a fit: Patients with drug-induced constipation or those who have undergone significant lifestyle changes recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a targeted and effective solution for patients suffering from chronic constipation linked to PIB infection.

How similar studies have performed: This approach is novel, as it targets a specific bacterial infection linked to constipation, which has not been extensively studied before.

Eligibility criteria

Inclusion Criteria:

Participants must meet all of the following criteria to enter the trial.

1. Signed written informed consent;
2. Age 18-70;
3. Diagnosed chronic functional constipation according to Rome III or IV criteria, and infected with PIB;
4. Patients who have not taken other types of antibiotics in the past 1 month;
5. Bowel organic lesions (tumors and severe inflammatory lesions, etc.) were excluded by colonoscopy in the past 2 years.
6. 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;

Exclusion Criteria:

Exclusion criteria: Subjects must exclude all of the following conditions to enter the study.

1. Pregnant and lactating women;
2. Patients with drug-induced constipation, including constipation induced by opioids and antidepressants;
3. During the study period, changes in lifestyle and dietary habits are not recommended in principle;
4. 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.
5. Those who cannot take samples and complete inspection items as required;
6. Allergic to levofloxacin; 7）Other researchers found it inappropriate to participate in the project for clinical manifestations or diseases.

Where this trial is running

Nanjing, Jiangsu

• Levofloxacin in the Treatment of Chronic Functional Constipation Associated With PIB Infection: A Multi-center, Exploratory Clinical Study — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Ji Xuan

Conditions Constipation; Levofloxacin; PIB; Peristaltic Contraction-Inhibiting Bacterium; constipation