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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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C. Difficile Enteritis

Intervention / Treatment
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* Dietary Supplement: Nagasin
* Dietary Supplement: maltodextrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiota | Gut microbiota diversity and taxonomic composition | at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI | 
| Abundance of antibiotic diarrhea associated pathogens | Abundance of other pathogens that are involved in antibiotic associated diarrhea e.g. S. aureus and K. oxytoca | at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI | 
| C. difficile toxins | Presence and amount of C. difficile toxins | at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI | 
| Toxin forming C. difficile strains | Presence of toxin forming C. difficile strains | at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut microbiota, Colonization resistance, Gut microbiota dysbiosis