Back to resultsSupport of Colonization Resistance of the Gut Microbiota With the Synbiotic Food Supplement Nagasin®
Primary Purpose
C. Difficile Enteritis
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Nagasin
maltodextrin
Sponsored by
About this trial
This is an interventional other trial for C. Difficile Enteritis focused on measuring Gut microbiota, Colonization resistance, Gut microbiota dysbiosis
Eligibility Criteria
Inclusion Criteria: C. difficile infection 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: parenteral nutrition insulin-dependent (type 1) diabetes severe disease defined as any of the following: WBC > 30,000 or < 1000 cells/mm3, elevated creatinine > 1.5 times the premorbid level, ICU patient at time C. difficile infection diagnosed. In case no values are available for WBC or creatinine presence of severe disease is evaluated by the local principal investigator or his designee. is severely immunocompromised (HIV with a low CD4 count, active malignancy receiving chemotherapy, long-term steroids) prosthetic heart valves or endocarditis consumption of other high-dose (>1010 cfu/dose) probiotic products during the study period. Inability to understand and follow study procedures
Sites / Locations
- University Hospital ZurichRecruiting
- Kantonsspital Winterthur
- Inselspital BernRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nagasin®
Comparator
Arm Description
consumption of Nagasin® (synbiotic food supplement) once per day for four weeks
consumption of the comparator (maltodextrin) once per day for four weeks
Outcomes
Primary Outcome Measures
C. difficile relative abundance
any change of C. difficile relative abundance during the first four weeks after antimicrobial treatment for CDI.
Secondary Outcome Measures
Gut microbiota
Gut microbiota diversity and taxonomic composition
Abundance of antibiotic diarrhea associated pathogens
Abundance of other pathogens that are involved in antibiotic associated diarrhea e.g. S. aureus and K. oxytoca
C. difficile toxins
Presence and amount of C. difficile toxins
Toxin forming C. difficile strains
Presence of toxin forming C. difficile strains
Full Information
NCT ID
NCT05800704
First Posted
March 23, 2023
Last Updated
May 8, 2023
Sponsor
University of Zurich
Collaborators
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT05800704
Brief Title
Support of Colonization Resistance of the Gut Microbiota With the Synbiotic Food Supplement Nagasin®
Official Title
Randomized, Controlled, Double-blind, Parallel, Multicentric Study to Investigate Support of the Colonization Resistance of the Gut Microbiota With the Synbiotic Food Supplement Nagasin® After Disturbance by Antimicrobial Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Insel Gruppe AG, University Hospital Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
C. Difficile Enteritis
Keywords
Gut microbiota, Colonization resistance, Gut microbiota dysbiosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
147 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nagasin®
Arm Type
Experimental
Arm Description
consumption of Nagasin® (synbiotic food supplement) once per day for four weeks
Arm Title
Comparator
Arm Type
Placebo Comparator
Arm Description
consumption of the comparator (maltodextrin) once per day for four weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Nagasin
Intervention Description
Lactobacillus, Lactococcus and Bifidobacteria strains with antimicrobial effect against C. difficile
Intervention Type
Dietary Supplement
Intervention Name(s)
maltodextrin
Intervention Description
maltodextrin (placebo comparator)
Primary Outcome Measure Information:
Title
C. difficile relative abundance
Description
any change of C. difficile relative abundance during the first four weeks after antimicrobial treatment for CDI.
Time Frame
at 1, 2 and 4 weeks after completion of antimicrobial treatment for CDI
Secondary Outcome Measure Information:
Title
Gut microbiota
Description
Gut microbiota diversity and taxonomic composition
Time Frame
at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI
Title
Abundance of antibiotic diarrhea associated pathogens
Description
Abundance of other pathogens that are involved in antibiotic associated diarrhea e.g. S. aureus and K. oxytoca
Time Frame
at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI
Title
C. difficile toxins
Description
Presence and amount of C. difficile toxins
Time Frame
at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI
Title
Toxin forming C. difficile strains
Description
Presence of toxin forming C. difficile strains
Time Frame
at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
C. difficile infection 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:
parenteral nutrition
insulin-dependent (type 1) diabetes
severe disease defined as any of the following: WBC > 30,000 or < 1000 cells/mm3, elevated creatinine > 1.5 times the premorbid level, ICU patient at time C. difficile infection diagnosed. In case no values are available for WBC or creatinine presence of severe disease is evaluated by the local principal investigator or his designee.
is severely immunocompromised (HIV with a low CD4 count, active malignancy receiving chemotherapy, long-term steroids)
prosthetic heart valves or endocarditis
consumption of other high-dose (>1010 cfu/dose) probiotic products during the study period.
Inability to understand and follow study procedures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle M Frey-Wagner, PhD
Phone
+41 76 426 33 10
Email
isabelle.frey@imm.uzh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle M Frey-Wagner, PhD
Organizational Affiliation
University or Zurich, Institute of Medical Microbiology
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Zurich
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc Biedermann, MD
Phone
+ 41 44 255 11 11
Email
luc.biedermann@usz.ch
Facility Name
Kantonsspital Winterthur
City
Winterthur
State/Province
Zurich
ZIP/Postal Code
8400
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Osthoff, MD
Phone
+41 52 266 2757
Email
michael.osthoff@ksw.ch
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Misselwitz
Phone
+41 31 664 04 30
Email
benjamin.misselwitz@insel.ch
12. IPD Sharing Statement
Plan to Share IPD
No
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Support of Colonization Resistance of the Gut Microbiota With the Synbiotic Food Supplement Nagasin®
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