Biomarkers for prediction of antibiotics induced changes and recovery of the oral and intestinal microbiome (Biopam)
- Conditions
- Dysbiosis induced by antibiotic therapy against a biopsy-proven bacterial infection in the gastrointestinal tractBacterial infections in the gastrointestinal tract confirmed by positive culture such as Helicobacter pylori infection
- Registration Number
- DRKS00020811
- Lead Sponsor
- Klinikum der Universität München
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 8
(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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of the study is to detect faecal biomarkers that might predict changes (dysbiosis) in composition and function of the oral and intestinal microbiome due to an antibiotic treatment.
- Secondary Outcome Measures
Name Time Method Therefore, we aim to investigate: <br>(a) which factors influence the change and recovery of the oral and intestinal microbiome before and after the antibiotic treatment, <br>(b) the diversity and function of oral and intestinal microbiome and metabolome in children with a bacterial gastrointestinal infection (baseline, prior antibiotic treatment), <br>(c) whether the intake of antibiotics for two weeks will affect the oral and intestinal microbiome.