Impact on the intestinal flora during antibiotic treatment

Phase 1

• Conditions: Effects of phenoximetylpenicillin, amoxicillin and amoxicillin-clavulanic acid on the gut microbiota of healthy volunteers; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-000953-30-SE
• Lead Sponsor: ppsala University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

- Signed written informed consent
- Age = 18 years

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 phenoximetylpenicillin, amoxicillin and amoxicillin-clavulanic acid
- 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 purpose of the study is to determine: (1) composition of intestinal microbiota and prevalence of resistant bacteria and resistance genes prior to and up to 1 year after antibiotic treatment, and (2) differences in the microbiota after treatment with three different antibiotics (phenoximetylpenicillin, amoxicillin and amoxicillin-clavulanic acid) compared to no treatment at all.<br> ;Secondary Objective: Not applicable ;Primary end point(s): The primary endpoint is the diversity and composition of the intestinal microbiota, the prevalence of multidrug-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, 12 and 24 months 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