Support of Colonization Resistance of the Gut Microbiota with the Synbiotic Food Supplement Nagasin® (NCT05800704) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Support of Colonization Resistance of the Gut Microbiota with the Synbiotic Food Supplement Nagasin®
Switzerland49 participantsStarted 2023-03-10
Plain-language summary
Double blind, placebo-controlled, parallel, multicentric trial to investigat whether Nagasin® can support the colonization resistance against C.difficile.
Who can participate
Age range
18 Years – 95 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cirrhosi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
C. difficile relative abundance
Timeframe: at 1, 2 and 4 weeks after completion of antimicrobial treatment for CDI