A pilot study, crossover randomized control trial on effect of oral calcium carbonate to fecal functional levofloxacin concentration in healthy volunteer taking oral levofloxaci
Phase 1
- Conditions
- We will study healthy volunteer if calcium carbonate can reduced functional fecal levofloxacin and protect fecal microbiome or not.1.Levofloxacin2.Calcium carbonate3.fecal functional level of levofloxacin4. Microbiota diversity5. Maximal plasma levofloxacin concentration(C max)
- Registration Number
- TCTR20210419003
- Lead Sponsor
- Royal College of Physician Thailand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
1.Healthy volunteer male or female age more than or equal 18 but less than 45 years old
2.No underlying disease
3.No history of receiving any medication within 1 month and no history of antibiotic use within 3 months
4.No history of drug allergy
5.Able to swallowing tablet medicine
6.No constipation
7.Body mass index range 18-25 kg/m2
8.eGFR (MDRD) > 60 ml/min/1.73m2
9.Normal liver function test, evaluated by physician
Exclusion Criteria
1During pregnancy or lactation
2Use of mineral or vitamin or herbal medicine supplementation within 1 month, especially metal compound such as iron, zinc, magnesium, calcium, aluminium or any vitamin etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method fecal functional level of levofloxacin 1 month after the end of intervention geometric mean and T test
- Secondary Outcome Measures
Name Time Method Gut microbiota diversity in healthy volunteers taking levofloxacin for 5 days by 16s rDNA sequencing 1 month after intervention T test