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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 49
- 试验地点
- 6
- 主要终点
- C. difficile relative abundance
研究概览
简要总结
Double blind, placebo-controlled, parallel, multicentric trial to investigat whether Nagasin® can support the colonization resistance against C.difficile.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Nagasin®
consumption of Nagasin® (synbiotic food supplement) once per day for four weeks
干预措施: Nagasin (Dietary Supplement)
Comparator
consumption of the comparator (maltodextrin) once per day for four weeks
干预措施: maltodextrin (Dietary Supplement)
结局指标
主要结局
C. difficile relative abundance
时间窗: 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.
次要结局
- Gut microbiota(at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI)
- Abundance of antibiotic diarrhea associated pathogens(at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI)
- C. difficile toxins(at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI)
- Toxin forming C. difficile strains(at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI)