A pilot study, randomized control trial on effect of oral calcium carbonate to fecal functional levofloxacin concentration in healthy volunteer taking oral levofloxacin
Abstract
Objective: We conducted a pilot randomized control trial (RCT) to study whether oral calcium carbonate (CaCO3) can lower fecal levofloxacin (LVX)�concentration and preserve gut microbiota diversity in healthy volunteers.
Methods: The healthy volunteers received a 5-day course of once-daily 500 mg LVX�oral tablet and were randomly assigned to treatment (6-day course of 1,000 mg CaCO3�oral tablet twice daily) and control group (no�CaCO3). The primary outcome was fecal LVX�concentration by MIC and high-performance liquid chromatography (HPLC) on day 2 and 5. The secondary outcomes were fecal microbiota diversity Shannon index (H) by 16s rDNA analysis, plasma LVX Cmax�by HPLC, and drug adverse events (AEs) in 4 weeks period.
Results: Total 20 volunteers were enrolled and randomly assigned to treatment and control group. Mean fecal LVX�concentration was higher in treatment than control group, 100.50 (SD=64.88) vs 53.21
(SD =39.57) ?g/ml by MIC at day 5 (95% CI 4.912, 89.73; p = 0.0242). No difference�in mean fecal LVX�concentrations by HPLC, plasma LVX Cmax. Treatment group had significantly declined in H index (p = 0.0019). Only mild AEs�included nausea and diarrhea.
Conclusion: CaCO3�is significantly related to higher fecal LVX�level by MIC but does not significantly affect the LVX Cmax. However, rather than protecting gut microbiota from LVX, CaCO3�may lower gut microbiota diversity in the presence of LVX. Therefore, co-prescription of LVX�and CaCO3�might be cautioned even…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 20 participants or records.
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