Impact on the intestinal flora during antibiotic treatment

Effects of phenoximetylpenicillin, amoxicillin and amoxicillin-clavulanic acid on the gut microbiota of healthy volunteers: a randomized clinical trail - EPAAC

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000953-30-SE

Enrollment

120

Registered

2019-03-18

Start date

2019-07-25

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Effects of phenoximetylpenicillin, amoxicillin and amoxicillin-clavulanic acid on the gut microbiota of healthy volunteers

Interventions

Trade Name: Phenoximetylpenicillin Product Name: fenoximetylpenicillin Pharmaceutical Form: Coated tablet Trade Name: Amoxicillin Produ

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. ;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.	—

Measure

Time frame

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. ;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.

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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 Hospital

thomas.tangden@medsci.uu.se0046708370323

Outcome results

None listed

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