NCT00958308已完成3 期
A Double-blind, Randomized, Placebo-controlled, Single-center Study of the Efficacy and Safety of BIO-K+ CL-1285® in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 255
- 主要终点
- To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Bio-K+ CL-1285 in the prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridum difficile-Associated Diarrhea (CDAD) in hospitalized patients exposed to nosocomial infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Antibiotic therapy for a minimum of 3 days and a maximum of 14 days
- •Expected to remain hospitalized for a minimum of 5 days
- •Patients who have received less than 36 hours of antibiotic therapy
- •Negative pregnancy test at screening
- •Obtained his/her informed consent after verbal and written information
- •Patients having a telephone available (mobile, work, home)
- •Patients having a fridge at home
排除标准
- •Pregnant or breastfeeding women
- •Patients presenting with active diarrhea (3 or more liquid stools per 24 hour period).
- •Patients with a history of daily consumption of probiotics, fermented milk and/or yogurt;
- •Patients known to have shown a previous reaction, including anaphylaxis, to any substance in composition of the study product (i.e. Non-medicinal ingredients: Cellulose, hypromellose, magnesium stearate (vegetal source), ascorbic acid, Colloidal silicon dioxide)
- •Patients presenting with an active, non-controlled intestinal disease such as Crohn's Disease or ulcerative colitis;
- •A previous documented C. Difficile infection < 3 months prior to study initiation ;
- •Ostomized patients, parenteral nutrition users
- •Patients with an immunosuppressive therapy or any health condition causing immunosuppression (including haematological malignancies, acquired immune deficiency syndrome (AIDS))
- •Ongoing or recent use of antibiotic therapy in the 30 days prior to the study product first administration.
- •Patients with planned administration of antibiotics other than broad spectrum Penicillin, Cephalosporin or Clindamycin for the treatment of an infection;
- •Patients with concomitant participation in another clinical trial;
- •Patients who are not likely to comply with study requirements
结局指标
主要结局
To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients.
时间窗: Up to 40 days
Incidence of AAD data were collected using questionnaire and diaries given to participants upon discharge. Diagnosis of AAD was made when a patient produced three or more liquid stools in a 24h period after antibiotic treatment with no other obvious reason for diarrhea.
次要结局
- Severity of AAD in Hospitalized Patients Ingesting BIO-K+CL1285® or Placebo.(Up to 40 days)
- Frequency of Stool Samples Positive for Clostridium Difficile (C. Difficile) Toxin A and/or B.(Up to 40 days)
- Safety Profile of BIO-K+CL1285® Versus Placebo in Hospitalized Patients.(Up to 40 days)
- Frequencies of Other Gastrointestinal Symptoms.(Up to 40 days)
研究者
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