NCT05800704

Brief Summary

Double blind, placebo-controlled, parallel, multicentric trial to investigat whether Nagasin® can support the colonization resistance against C.difficile.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

2.1 years

First QC Date

March 23, 2023

Last Update Submit

March 24, 2025

Conditions

C. Difficile Enteritis

Keywords

Gut microbiotaColonization resistanceGut microbiota dysbiosis

Outcome Measures

Primary Outcomes (1)

  • C. difficile relative abundance

    any change of C. difficile relative abundance during the first four weeks after antimicrobial treatment for CDI.

    at 1, 2 and 4 weeks after completion of antimicrobial treatment for CDI

Secondary Outcomes (4)

  • Gut microbiota

    at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI

  • Abundance of antibiotic diarrhea associated pathogens

    at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI

  • C. difficile toxins

    at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI

  • Toxin forming C. difficile strains

    at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI

Study Arms (2)

Nagasin®

EXPERIMENTAL

consumption of Nagasin® (synbiotic food supplement) once per day for four weeks

Dietary Supplement: Nagasin

Comparator

PLACEBO COMPARATOR

consumption of the comparator (maltodextrin) once per day for four weeks

Dietary Supplement: maltodextrin

Interventions

NagasinDIETARY_SUPPLEMENT

Lactobacillus, Lactococcus and Bifidobacteria strains with antimicrobial effect against C. difficile

Nagasin®
maltodextrinDIETARY_SUPPLEMENT

maltodextrin (placebo comparator)

Comparator

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Kantonsspital Baselland

Liestal, Basel-Landschaft, 4410, Switzerland

Location

Inselspital Bern

Bern, Canton of Bern, 3010, Switzerland

Location

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8400, Switzerland

Location

Stadtspital Zürich

Zurich, Canton of Zurich, 8063, Switzerland

Location

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Interventions

maltodextrin

Study Officials

  • Isabelle M Frey-Wagner, PhD

    University or Zurich, Institute of Medical Microbiology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2023

First Posted

April 6, 2023

Study Start

March 10, 2023

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(6)