C. Difficile Enteritis
Conditions
Keywords
Gut microbiota, Colonization resistance, Gut microbiota dysbiosis
Brief summary
Double blind, placebo-controlled, parallel, multicentric trial to investigat whether Nagasin® can support the colonization resistance against C.difficile.
Detailed description
The aim of this randomized, controlled, double-blind, parallel, multicentric trial is to investigate wether the synbiotic food supplement Nagasin® can support the colonization resistance of the gut microbiota after disturbance by antimicrobial treatment. The main question is whether Nagasin® can prevent any increase in abundance of C.difficile within the first four weeks after antimicrobial treatment for a C. difficile infection. Participants will receive Nagasin® or the comparator as a food supplement during the first four weeks after antimicrobial treatment for a C. difficile episode.
Interventions
DIETARY_SUPPLEMENTNagasin
Lactobacillus, Lactococcus and Bifidobacteria strains with antimicrobial effect against C. difficile
DIETARY_SUPPLEMENTmaltodextrin
maltodextrin (placebo comparator)
Sponsors
Insel Gruppe AG, University Hospital Bern
Stadtspital Zürich
Kantonsspital Winterthur KSW
Luzerner Kantonsspital
Cantonal Hosptal, Baselland
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C. difficile relative abundance | at 1, 2 and 4 weeks after completion of antimicrobial treatment for CDI | any change of C. difficile relative abundance during the first four weeks after antimicrobial treatment for CDI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiota | at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI | Gut microbiota diversity and taxonomic composition |
| Abundance of antibiotic diarrhea associated pathogens | at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI | Abundance of other pathogens that are involved in antibiotic associated diarrhea e.g. S. aureus and K. oxytoca |
| C. difficile toxins | at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI | Presence and amount of C. difficile toxins |
| Toxin forming C. difficile strains | at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI | Presence of toxin forming C. difficile strains |
Countries
Switzerland
Outcome results
None listed