Impact on the intestinal flora during antibiotic treatment

Phase 1

• Conditions: Impact on the intestinal microbiota during antibiotic treatment; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-003704-31-SE
• Lead Sponsor: ppsala University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-03
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 120

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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.<br> ;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 Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable ;Timepoint(s) of evaluation of this end point: Not applicable