Levofloxacin in the Treatment of Chronic Functional Constipation Associated With PIB(Peristaltic Contraction-Inhibiting Bacterium) Infection
- Conditions
- Constipation
- Registration Number
- NCT06571097
- Lead Sponsor
- Haifeng Lan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria:<br><br>Participants must meet all of the following criteria to enter the trial.<br><br> 1. Signed written informed consent;<br><br> 2. Age 18-70;<br><br> 3. Diagnosed chronic functional constipation according to Rome III or IV criteria, and<br> infected with PIB;<br><br> 4. Patients who have not taken other types of antibiotics in the past 1 month;<br><br> 5. Bowel organic lesions (tumors and severe inflammatory lesions, etc.) were excluded<br> by colonoscopy in the past 2 years.<br><br> 6. The subjects could follow the follow-up plan, objectively describe the symptoms, and<br> cooperate with the completion of the scale; 7)Agree to maintain similar diet and<br> activity levels from the screening visit to the end of the study;<br><br>Exclusion Criteria:<br><br>Exclusion criteria: Subjects must exclude all of the following conditions to enter the<br>study.<br><br> 1. Pregnant and lactating women;<br><br> 2. Patients with drug-induced constipation, including constipation induced by opioids<br> and antidepressants;<br><br> 3. During the study period, changes in lifestyle and dietary habits are not recommended<br> in principle;<br><br> 4. Patients with diseases that affect the conduct or results of the study, such as<br> mental illness, serious cardiopulmonary, liver and kidney diseases, history of<br> gastrointestinal surgery, epilepsy, etc.<br><br> 5. Those who cannot take samples and complete inspection items as required;<br><br> 6. Allergic to levofloxacin; 7)Other researchers found it inappropriate to participate<br> in the project for clinical manifestations or diseases.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total effective rate of levofloxacin in the treatment of chronic functional constipation.
- Secondary Outcome Measures
Name Time Method PIB concentration (DPA content of docosapentaenoic acid);Proportion of patients with first defecation;Time of first defecation;Number of frequency of use of rescue drugs and other Other defecation medications per week;PAC-SYM;PAC-QoL scale;Bristol scale;The incidence of serious adverse events;Patient satisfaction with treatment survey