Microbiome changes due to antibiotic prophylaxis in mothers at birth

Conditions: Microbiome examination after cesarean section or vaginal delivery, respectively

Registration Number: DRKS00027305

Lead Sponsor: Kliniken der Stadt Köln gGmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 37

Inclusion Criteria

Willingness to participate in the study (informed consent);
Planned caesarean section in the next 4 weeks (group I);
Expected vaginal delivery in the next 8 weeks (group II = control);
Age = 18 years

Exclusion Criteria

Participation in another study;
Use of immunosuppressants, antivirals, cytostatics, proton pump inhibitors (PPIs);
Systemic use of other antibiotics, antifungals, fungicides during the past 3 months;
Foreseeable need for antibiotics other than cefuroxime or planned surgery in the next 90 days;
Chronic viral disease (HIV, HBV, HCV);
Chronic intestinal disease (such as Crohn's disease or ulcerative colitis);
Underlying hematologic or oncologic diseases;
chronic kidney or liver disease

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of subjects with a change in biodiversity (alpha-diversity) from T0 to T1

Secondary Outcome Measures

Name	Time	Method
umber of subjects in which the microbiome at T2 has returned to T0 after a change at T1;<br>Difference in biodiversity (beta-diversity) T0 to T1;<br>Difference in biodiversity (beta-diversity) T1 to T2;<br>Difference in biodiversity (beta-diversity) T0 to T2;<br>Type and number of reduced bacterial orders;<br>Number of subjects in which potential pathogens such as Clostridioides difficile are newly observed;<br>Number of subjects in which potentially health-promoting bacteria such as Bifidobacteria increase;<br>Increase in resistance genes (PCR)