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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-10

Study Completion Date

2025-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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C. Difficile Enteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nagasin®

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

Group Type EXPERIMENTAL

Nagasin

Intervention Type DIETARY_SUPPLEMENT

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

Comparator

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

Group Type PLACEBO_COMPARATOR

maltodextrin

Intervention Type DIETARY_SUPPLEMENT

maltodextrin (placebo comparator)

Interventions

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Nagasin

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

Intervention Type DIETARY_SUPPLEMENT

maltodextrin

maltodextrin (placebo comparator)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No