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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00020811
Enrollment
40
Registered
2020-03-10
Start date
2020-03-15
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Dysbiosis induced by antibiotic therapy against a biopsy-proven bacterial infection in the gastrointestinal tract Bacterial infections in the gastrointestinal tract confirmed by positive culture such as Helicobacter pylori infection

Interventions

Group 1: In this study, we collect saliva and faecal samples of 60 children and teenagers with a bacterial infection in the gastrointestinal tract, who require a treatment with antibiotics according t

Sponsors

Klinikum der Universität München
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years

Inclusion criteria

Inclusion criteria: (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).

Exclusion criteria

Exclusion criteria: (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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Therefore, we aim to investigate: (a) which factors influence the change and recovery of the oral and intestinal microbiome before and after the antibiotic treatment, (b) the diversity and function of oral and intestinal microbiome and metabolome in children with a bacterial gastrointestinal infection (baseline, prior antibiotic treatment), (c) whether the intake of antibiotics for two weeks will affect the oral and intestinal microbiome.

Countries

Germany, Portugal, Slovenia, Spain

Contacts

Public ContactThu Giang Le Thi

Dr. von Haunersches KinderspitalAbt. Pädiatrische Gastroenterologie & HepatologieKlinikum der Universitaet Muenchen (AöR)

tlethi@med.lmu.de+4989440057854

Outcome results

None listed

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