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
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
研究组 & 干预措施
Placebo
Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
干预措施: Placebo (Other)
BIO-K+ CL-1285
Two probiotic capsules (BIO-K+ CL-1285®) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
干预措施: BIO-K+ CL-1285® (Other)
BIO-K+ CL-1285® & placebo
One probiotic capsule (BIO-K+ CL-1285®) and one placebo capsule (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
干预措施: BIO-K+ CL-1285® (Other)
BIO-K+ CL-1285® & placebo
One probiotic capsule (BIO-K+ CL-1285®) and one placebo capsule (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
干预措施: Placebo (Other)
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)