Microbiome changes due to antibiotic prophylaxis in mothers at birth
We are conducting an exploratory, unblinded, monocentric, two-arm, non-interventional, observational study of dysbiosis due to prophylactic administration of cefuroxime.
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Our study will demonstrate for the first time the qualitative and quantitative effects of a single prophylactic administration of intravenous cefuroxime (perioperative antibiotic prophylaxis, PAP) during caesarean section on the gut microbiome of delivering women and whether recolonization is achieved within 90 days. A group of vaginally delivering women without prophylactic antibiosis will serve as control to distinguish effects due to the end of pregnancy from effects due to cefuroxime administration.
The aim of the study is the recruitment of 25 subjects for each of the two study arms (50 patients in total), who complete study participation and provide three stool samples.
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Subjects of both groups will be asked to provide spontaneous stool samples at three time points (T0 before delivery, T1 and T2 after delivery). At the end of recruitment phase, they will be forwarded to the Institute of Medical Microbiology, Immunology and Parasitology (IMMIP) at the University Hospital Bonn for analysis. PCR of the 16S rRNA gene (V3-V4 region) is used to qualitatively and quantitatively determine the intestinal microbiome and measure its changes. Biostatistical evaluation will be performed in cooperation with the Institute for Functional Gene Analytics (IFGA) at the Hochschule Bonn-Rhein-Sieg (H-BRS), University of Applied Sciences. We will analyze changes in biodiversity (α- and β-diversity) over time (T0 to T1, T1 to T2, T0 to T2) and between the two study arms (with or without PAP) as well possible recolonization at time point T2.
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Stool samples are taken by the participants themselves at home or (in case of prolonged inpatient treatment after delivery) in the hospital. Patients have been instructed about the procedure in verbal and written form. The samples are temporarily stored at the Institute of Hygiene at the Cologne Merheim Medical Centre.
Patients are recruited at two level 1 perinatal centers: Women’s Clinic Holweide, Cologne Merheim Medical Centre and St. Marien Hospital, GFO Clinics Bonn. The study is conducted in cooperation with the German Aerospace Center (Deutsches Zentrum für Luft- und Raumfahrt, DLR, Prof. Dr. Ralf Möller), University of Applied Sciences Bonn-Rhein-Sieg (Hochschule Bonn-Rhein-Sieg, HBRS, Prof. Dr. Martin Sieber) and the Institute for Medical Microbiology, Immunology and Parasitology (IMMIP, Dr. Claudio Neidhöfer) of the University Hospital Bonn (UKB) in the context of a doctoral thesis (PhD student: Elisabeth Feles, pharmacist) at Witten/Herdecke University under the supervision of Prof. Dr. Frauke Mattner (Division of Hygiene and Environmental Medicine, Department of Human Medicine, Faculty of Health).
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Study Coordinator MAMA-Study
Kliniken der Stadt Köln
Institut für Hygiene, Haus 34
Ostmerheimer Straße 200
Tel.: +49 221 8907-13438
The MAMA study is financed by research funds of Institute of Hygiene, Cologne Merheim Medical Centre, University Hospital of Witten/Herdecke.