Support of Colonization Resistance of the Gut Microbiota with the Synbiotic Food Supplement Nagasin® (NCT05800704) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Support of Colonization Resistance of the Gut Microbiota with the Synbiotic Food Supplement Nagasin®
Switzerland49 participantsStarted 2023-03-10
Plain-language summary
Double blind, placebo-controlled, parallel, multicentric trial to investigat whether Nagasin® can support the colonization resistance against C.difficile.
Who can participate
Age range18 Years – 95 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cirrhosi…
What they're measuring
1
C. difficile relative abundance
Timeframe: at 1, 2 and 4 weeks after completion of antimicrobial treatment for CDI