Clinical trial NCT05800704: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: C. Difficile Enteritis
Keywords: Gut microbiota
Colonization resistance
Gut microbiota dysbiosis
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
name: Stadtspital Zürich
name: Kantonsspital Winterthur KSW
name: Luzerner Kantonsspital
name: Cantonal Hosptal, Baselland
First posted: 2023-04-06
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: C. difficile relative abundance
timeFrame: at 1, 2 and 4 weeks after completion of antimicrobial treatment for CDI
Secondary outcomes:
measure: Gut microbiota
timeFrame: at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI
measure: Abundance of antibiotic diarrhea associated pathogens
timeFrame: at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI
measure: C. difficile toxins
timeFrame: at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI
measure: Toxin forming C. difficile strains
timeFrame: at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI
Other outcomes:
Locations:
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland
state: BL
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
state: LU
city: Zurich
country: Switzerland
facility: University Hospital Zurich
state: ZH
city: Zürich
country: Switzerland
facility: Stadtspital Zürich
state: ZH
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Zurich
city: Bern
country: Switzerland
facility: Inselspital Bern
Study officials:
affiliation: University or Zurich, Institute of Medical Microbiology
name: Isabelle M Frey-Wagner, PhD
role: STUDY_CHAIR
References: