Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT05800704
Eligibility Criteria:
Inclusion Criteria:
* C. difficile infection (CDI) diagnosis
* antimicrobial treatment (e.g. metronidazole, vancomycin or fidaxomicin) for C. difficile infection at ICF
* Written informed consent by the participant after information about the research project
Exclusion Criteria:
* total parenteral nutrition
* insulin-dependent (type 1) diabetes
* severe disease defined as any of the following:
* White blood cell count (WBC) \> 30,000 or \< 1000 cells/mm3
* Neutropenia \< 500 x 10\^9 per liter
* Intensive care unit (ICU) patient at time C. difficile infection diagnosed
* In case no hematology values are available, presence of severe can be evaluated by the local principal investigator or his designee
* is severely immunocompromised as defined by any of the following:
* active malignancy receiving severe immunosuppressive chemotherapy with subsequent leukopenia (as defined above)
* long-term systemic steroid therapy ≥ 30 mg / d
* recipients of stem cell transfer (≤ 12 months)
* severe inborn immune deficiency or severe immunosuppressive therapy as evaluated by the investigator
* HIV patients with low CD4+ cell count (\< 200 x 10\^9 per liter)
* Inflammatory bowel disease patients if:
* severe ulcerative colitis (classified as endoscopic Mayo = 3 (max. 30 days old) or as evaluated by investigator)
* Severe Crohn's disease with acute penetrating complication (abscess and/or actively draining fistulae) or as evaluated by investigator
* Liver cirrhosis (classified as Child C) with clinically significant portal hypertension and/or low thrombocyte count (20 × 10\^9 per liter)
* Acute pancreatitis
* prosthetic heart valves or endocarditis
* consumption of other high-dose (\>10\^10 cfu/dose) probiotic products during the study period.
* Inability to understand and follow study procedures
* prosthetic heart valves or endocarditis
* consumption of other high-dose (\>10\^10 cfu/dose) probiotic products during the study period.
* Inability to understand and follow study procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
95 Years
Study:
NCT05800704
Study Brief:
Protocol Section:
NCT05800704