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

Sponsor

University of Zurich (Other)

Overall Status

Recruiting

CT.gov ID

NCT05800704

Collaborator

University Hospital Inselspital, Berne (Other)

147

Enrollment

Locations

Arms

21.4

Anticipated Duration (Months)

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
C. Difficile Enteritis Gut Microbiota Dysbiosis	Dietary Supplement: Nagasin Dietary Supplement: maltodextrin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

147 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

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

Actual Study Start Date :

Mar 10, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Dec 20, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nagasin® consumption of Nagasin® (synbiotic food supplement) once per day for four weeks	Dietary Supplement: Nagasin Lactobacillus, Lactococcus and Bifidobacteria strains with antimicrobial effect against C. difficile
Placebo Comparator: Comparator consumption of the comparator (maltodextrin) once per day for four weeks	Dietary Supplement: maltodextrin maltodextrin (placebo comparator)

Arm

Intervention/Treatment

Experimental: Nagasin®

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

Dietary Supplement: Nagasin

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

Placebo Comparator: Comparator

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

Dietary Supplement: maltodextrin

maltodextrin (placebo comparator)

Outcome Measures

Primary Outcome Measures

C. difficile relative abundance [at 1, 2 and 4 weeks after completion of antimicrobial treatment for CDI]
any incidence in increase of C. difficile relative abundance during the first four weeks after antimicrobial treatment for CDI.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. difficile infection diagnosis
antimicrobial treatment (Metronidazol, 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich	Zurich	ZH	Switzerland	8091
2	Kantonsspital Winterthur	Winterthur	Zurich	Switzerland	8400
3	Inselspital Bern	Bern		Switzerland	3010

Sponsors and Collaborators

University of Zurich
University Hospital Inselspital, Berne

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Zurich

ClinicalTrials.gov Identifier:

NCT05800704

Other Study ID Numbers:

BASEC 2022-01318

First Posted:

Apr 6, 2023

Last Update Posted:

Apr 6, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Zurich

Gut microbiota

Colonization resistance

Additional relevant MeSH terms:

Enteritis

Dysbiosis

Study Results

No Results Posted as of Apr 6, 2023