Status:
RECRUITING
Levofloxacin in the Treatment of Chronic Functional Constipation Associated With PIB(Peristaltic Contraction-Inhibiting Bacterium) Infection
Lead Sponsor:
Haifeng Lan
Conditions:
Constipation
Eligibility:
All Genders
18-70 years
Phase:
NA
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 encompa...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- Exclusion criteria: Subjects must exclude all of the following conditions to enter the study.
- 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.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06571097
Start Date
July 1 2024
End Date
June 1 2025
Last Update
August 26 2024
Active Locations (1)
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Levofloxacin in the Treatment of Chronic Functional Constipation Associated With PIB Infection: A Multi-center, Exploratory Clinical Study
Nanjing, Jiangsu, China, 210000