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A pilot study, crossover randomized control trial on effect of oral calcium carbonate to fecal functional levofloxacin concentration in healthy volunteer taking oral levofloxacin

A pilot study, crossover randomized control trial on effect of oral calcium carbonate to fecal functional levofloxacin concentration in healthy volunteer taking oral levofloxacin

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210419003
Enrollment
16
Registered
2021-04-19
Start date
2021-06-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

We will study healthy volunteer if calcium carbonate can reduced functional fecal levofloxacin and protect fecal microbiome or not. 1.Levofloxacin 2.Calcium carbonate 3.fecal functional level of levofloxacin 4. Microbiota diversity 5. Maximal plasma levofloxacin concentration(C max)

Interventions

Taking 1000 mg oral tablet calcium carbonate twice daily before meal (1st dose on 12:00-1:00 p.m. and 2nd dose 6:00-7:00 p.m.) duration for 6 days and start 1 day before levofloxacin. Taking 500 mg or
Experimental Drug,No Intervention No treatment
Calcium carbonate,No calcium carbonate

Sponsors

Royal College of Physician Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

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

Exclusion criteria: 1 During pregnancy or lactation 2 Use 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.

Design outcomes

Primary

MeasureTime frame
fecal functional level of levofloxacin 1 month after the end of intervention geometric mean and T test

Secondary

MeasureTime frame
Gut microbiota diversity in healthy volunteers taking levofloxacin for 5 days by 16s rDNA sequencing 1 month after intervention T test

Countries

Thailand

Contacts

Public ContactOphat Janphet

Division of Infectious Disease, Department of Medicine, Faculty of Medicine, Chulalongkorn University

noble_p@hotmail.com0872309250

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026