C. Difficile EnteritisNCT05800704
Support of Colonization Resistance of the Gut Microbiota with the Synbiotic Food Supplement Nagasin®
A study testing Nagasin and maltodextrin in people with C. Difficile Enteritis, run by University of Zurich at 6 sites in Switzerland.
Trial summary
Double blind, placebo-controlled, parallel, multicentric trial to investigat whether Nagasin® can support the colonization resistance against C.difficile. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- C. Difficile Enteritis
- What is being tested?
- Nagasin and maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 6 sitesSwitzerland
- Study dates
- 10 Mar 2023to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Switzerland6 sites
Inselspital Bern
Bern, Canton of Bern, 3010
Kantonsspital Baselland
Liestal, Basel-Landschaft, 4410
Luzerner Kantonsspital
Lucerne, Canton of Lucerne, 6000
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8400
Stadtspital Zürich
Zurich, Canton of Zurich, 8063
University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
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
Double blind, placebo-controlled, parallel, multicentric trial to investigat whether Nagasin® can support the colonization resistance against C.difficile.
Read the 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.
- Conditions
- C. Difficile Enteritis
- Being tested
- Nagasin, maltodextrin
- Keywords
- Gut microbiota, Colonization resistance, Gut microbiota dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NagasinDietary supplement
Lactobacillus, Lactococcus and Bifidobacteria strains with antimicrobial effect against C. difficile
maltodextrinDietary supplement
maltodextrin (placebo comparator)
| Study group | Role | What they receive |
|---|---|---|
| Nagasin® | Experimental | consumption of Nagasin® (synbiotic food supplement) once per day for four weeks Receives: Dietary Supplement: Nagasin |
| Comparator | Placebo comparator | consumption of the comparator (maltodextrin) once per day for four weeks Receives: Dietary Supplement: maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
C. difficile relative abundance
any change of C. difficile relative abundance during the first four weeks after antimicrobial treatment for CDI.
Measured: at 1, 2 and 4 weeks after completion of antimicrobial treatment for CDI
Secondary outcomes (4)
Gut microbiota
Gut microbiota diversity and taxonomic composition
Measured: 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
Measured: at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI
C. difficile toxins
Presence and amount of C. difficile toxins
Measured: 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
Measured: at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start10 Mar 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C. Difficile EnteritisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, Stadtspital Zürich, Kantonsspital Winterthur KSW, Luzerner Kantonsspital, Cantonal Hospital, Baselland
- Responsible party
- Sponsor
- Investigators
- Isabelle M Frey-Wagner, PhD, Study chair, University or Zurich, Institute of Medical Microbiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800704
- Sponsor's protocol ID
- BASEC 2022-01318
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2023
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05800704
- Acronym / sponsor ID
- BASEC 2022-01318
- Conditions
- C. Difficile Enteritis
- Keywords
- Gut microbiota, Colonization resistance, Gut microbiota dysbiosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, Stadtspital Zürich, Kantonsspital Winterthur KSW, Luzerner Kantonsspital, Cantonal Hospital, Baselland
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nagasin® | Experimental | Dietary Supplement: Nagasinconsumption of Nagasin® (synbiotic food supplement) once per day for four weeks |
| Comparator | Placebo comparator | Dietary Supplement: maltodextrinconsumption of the comparator (maltodextrin) once per day for four weeks |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (24 listed)
- total parenteral nutrition
- insulin-dependent (type 1) diabetes
- severe disease defined as any of the following:
- is severely immunocompromised as defined by any of the following:
- Acute pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NagasinLactobacillus, Lactococcus and Bifidobacteria strains with antimicrobial effect against C. difficile | Dietary supplement | Nagasin® |
| maltodextrinmaltodextrin (placebo comparator) | Dietary supplement | Comparator |
Primary outcome
C. difficile relative abundance
Time frame: at 1, 2 and 4 weeks after completion of antimicrobial treatment for CDI
any change of C. difficile relative abundance during the first four weeks after antimicrobial treatment for CDI.
4 secondary outcomes
Gut microbiota
Time frame: at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI
Abundance of antibiotic diarrhea associated pathogens
Time frame: at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI
C. difficile toxins
Time frame: at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI
Toxin forming C. difficile strains
Time frame: at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle M Frey-Wagner, PhD study chair
University or Zurich, Institute of Medical Microbiology
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nagasin and maltodextrin in people with C. Difficile Enteritis, run by University of Zurich at 6 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C. difficile relative abundance (time frame: at 1, 2 and 4 weeks after completion of antimicrobial treatment for CDI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.