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

Not Applicable

Active, not recruiting

• Conditions: C. Difficile Enteritis
• Interventions: Dietary Supplement: Nagasin; Dietary Supplement: maltodextrin

• Registration Number: NCT05800704
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study Start: 2023-03-10
• Study First Submitted: 2023-03-23
• Study First Submitted QC: 2023-03-23
• Study First Posted: 2023-04-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nagasin®	Nagasin	consumption of Nagasin® (synbiotic food supplement) once per day for four weeks
Comparator	maltodextrin	consumption of the comparator (maltodextrin) once per day for four weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Kantonsspital Baselland; 🇨🇭 Liestal, BL, Switzerland

Luzerner Kantonsspital; 🇨🇭 Luzern, LU, Switzerland

University Hospital Zurich; 🇨🇭 Zurich, ZH, Switzerland

Stadtspital Zürich; 🇨🇭 Zürich, ZH, Switzerland

Kantonsspital Winterthur; 🇨🇭 Winterthur, Zurich, Switzerland

Inselspital Bern; 🇨🇭 Bern, Switzerland