Multicenter, prospective cohort study on microbiota-defined and clinical risk factors for Clostridium difficile colonization and -associated disease in patient groups at risk

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00005335

Enrollment

2000

Registered

2013-10-14

Start date

2013-10-21

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

A04.7

Interventions

Group 1: Questionaire, patient questionaire, stool sample

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inpatients with underlying diseases causing in increased risk of C. difficile colonization/CDAD: a) malignant disease, b) s/p stem cell or solid organ transplantation, c) infiammatory bowel disease, d) hemodialysis, written informed consent

Exclusion criteria

Exclusion criteria: CDAD or suspected CDAD within 30 days prior to enrollment; diseases which prevent candidates to understand the nature and the consequences of the clinical trial; indications for protocol non-compliance

Design outcomes

Secondary

Measure	Time frame
Proportion of patients with CDAD, microbial pattern at baseline and at the final visit in colonized patients, microbial pattern at baseline and at the final visit in CDAD patients, disease course (severity, complications, recurrences) of CDAD, IgA and IgG repertoires in blood and intestinal mucosal samples	—

Primary

Measure	Time frame
Proportion of patients with C. difficile colonization and -associated disease	—

Countries

Germany

Contacts

Public ContactOlesya Unruh

MHH OE6810

unruh.olesya@mh-hannover.de+495115323489

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 18, 2026