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

University of Zurich (UZH)

Status: Active, not recruiting

Conditions: C. Difficile Enteritis

Treatments: Dietary Supplement: Nagasin; Dietary Supplement: maltodextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT05800704

BASEC 2022-01318

Details and patient eligibility

About

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

Full 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.

Enrollment: 49 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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49 participants in 2 patient groups, including a placebo group

Nagasin®

Experimental group

Description:

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

Treatment:

Dietary Supplement: Nagasin

Comparator

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: maltodextrin