Biomarkers for prediction of antibiotics induced changes and recovery of the oral and intestinal microbiome (Biopam) - BIOPAM

Klinikum der Universität München0 个研究点目标入组 8 人开始时间: 2020年3月10日最近更新: 2024年8月19日

试验速览

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•(a) Male or female patients aged between 5 - 18 years.
•(b) Minimal body weight of 15 kg.
•(c) A bacterial biopsy proven gastrointestinal infection confirmed by positive culture and results of the antibiotic susceptibility testing are available.
•(d) No previous antibiotic therapy against bacterial GI infection including H. pylori infection.
•(e) Written informed consent by parents/care giver and patients (6-11 years and >11-17 years).

•(a) Acute intestinal infection with systemic signs (high fever, sepsis) requiring i.e. antibiotics.
•(b) Significant chronic gastrointestinal disease such as inflammatory bowel disease (IBD), celiac disease, eosinophilic esophagitis (EoE) or severe acquired or primary immunodeficiency.
•(c) Patients with duodenal or gastric ulcers who need to be treated immediately with proton pump inhibitor (PPI) according to the physician’s judgment after endoscopy.
•(d) Patients with active gastrointestinal bleeding
•(e) Patients with history of gastric surgery
•(f) Known allergies to used antibiotics or proton pump inhibitors.
•(g) Having received treatment with antibiotics or bismuth compounds during the previous 6 months.
•(h) Having received proton pump inhibitors during the previous 14 days prior to the day patient starts taking antibiotic combination.
•(i) Having consumed any probiotics or probiotic combinations 14 days before and during study participation.
•(j) Being infected with a multi-drug resistant strain.

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