Impact on the intestinal flora during antibiotic treatment

Impact on the intestinal microbiota during antibiotic treatment

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003704-31-SE

Enrollment

120

Registered

2017-01-03

Start date

2019-05-17

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Impact on the intestinal microbiota during antibiotic treatment

Interventions

Trade Name: Ciprofloxacin Product Name: Ciprofloxacin Pharmaceutical Form: Coated tablet Trade Name: Cedax Product Name: Ceftibuten

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - At least 18 years of age - Signed written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Chronic disease, allergy, asthma, recurrent infections - Ongoing antibiotic treatment - Antibiotic treatment the last 12 months - Pregnancy or planned pregnancy within the study period - Known allergy to ciprofloxacin, pivmecillinam, nitrofurantoin, trimetoprim-sulfametoxazol, ceftibuten - Planned travel outside Europe within one year from inclusion

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the study is: (1) to identify the composition and diversity of the intestinal microbiota and the presence of resistant bacteria and resistance genes, before and up to 1 years after antibiotic treatment (2) and to compare the impact of three different antibiotics (ciprofloxacin, pivmecillinam och ceftibuten) on the microbiota. ;Secondary Objective: Not applicable;Primary end point(s): The primary endoint is the diversity and composition of the intestinal microbiota, the prevalence of multi drug-resistant Gram-negative bacteria in screening cultures and the prevalence of antibiotic resistance genes in faeces. ;Timepoint(s) of evaluation of this end point: Endpoints will be assessed at repeated time points during the study period: before start of treatment, after completion of treatment, after 7 days and 1, 3, 6 and 12 month after completion of treatment.	—

Measure

Time frame

Main Objective: The objective of the study is: (1) to identify the composition and diversity of the intestinal microbiota and the presence of resistant bacteria and resistance genes, before and up to 1 years after antibiotic treatment (2) and to compare the impact of three different antibiotics (ciprofloxacin, pivmecillinam och ceftibuten) on the microbiota. ;Secondary Objective: Not applicable;Primary end point(s): The primary endoint is the diversity and composition of the intestinal microbiota, the prevalence of multi drug-resistant Gram-negative bacteria in screening cultures and the prevalence of antibiotic resistance genes in faeces. ;Timepoint(s) of evaluation of this end point: Endpoints will be assessed at repeated time points during the study period: before start of treatment, after completion of treatment, after 7 days and 1, 3, 6 and 12 month after completion of treatment.

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable ;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Sweden

Contacts

Public ContactDepartment of infectious diseases

Uppsala University

thomas.tangden@medsci.uu.se0046708370323

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026