Support of Colonization Resistance of the Gut Microbiota with the Synbiotic Food Supplement Nagasin®

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.

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