Developing Microbials to Fight Extended-spectrum Beta-lactamase (ESBL)-Producing Escherichia Coli

Active, not recruiting

• Conditions: Extended Spectrum Beta Lactamases (ESBL) E. Coli
• Interventions: Other: examination of stool sample; Other: patient questionnaire; Other: examination of blood sample

• Registration Number: NCT04764500
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

This study is to identify and isolate well-defined microbials (non-ESBL E. coli) in an observational setting exploring natural gastrointestinal decolonization of humans colonized with ESBL E. coli.

Detailed Description

Antibiotic resistance is a severe threat to contemporary medicine. Effective approaches to fight multi-drug resistant pathogenic bacteria are needed.

This clinical observational study is to investigate whether express extended spectrum beta lactamases (ESBL) E. coli colonizing the human gut can be out-competed by other, ideally pan-sensitive strains (non-ESBL E. coli).

Study Timeline

• Study Start: 2019-06-13
• Primary Completion: 2020-02-09
• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-03
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• travelling to Southeast Asia (India, Bhutan, Nepal, Bangladesh, Myanmar, Thailand, Laos, Cambodia, Vietnam) for a maximum of 4 weeks.

Exclusion Criteria

• other travelling destinations than mentioned above
• antibiotic use at the first sampling time
• Participants who are not colonized will serve as a control group for microbiome comparison

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
travellers to Southeast Asia	examination of stool sample	Clients planning to travel to Southeast Asia will be recruited
travellers to Southeast Asia	patient questionnaire	Clients planning to travel to Southeast Asia will be recruited
travellers to Southeast Asia	examination of blood sample	Clients planning to travel to Southeast Asia will be recruited

Primary Outcome Measures

Name	Time	Method
proportion of patients being "naturally" decolonized from ESBL E. coli	18 months	proportion of patients being "naturally" decolonized from ESBL E. coli at the end of the study period at 18 months

Trial Locations

Locations (1)

University Hospital Basel, Division of Clinical Microbiology; 🇨🇭 Basel, Switzerland