Feasibility Study of Probiotics in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Rate of antibiotic associated diarrhea
研究概览
简要总结
Antibiotics are lifesaving medicines and generally safe, yet unwanted side effects are common. While destroying illness-causing 'bad' bacteria, antibiotics can upset the protective 'good' bacteria in the body. This research will test if taking a probiotic with prescribed antibiotics will decrease the chance of having bothersome antibiotic-associated side effects.
详细描述
Objectives Several studies have demonstrated that probiotics can be helpful in preventing antibiotic-associated diarrhoea in hospitalized patients. However, the extent to which probiotics may benefit healthy adults taking a course of antibiotics has not been investigated in primary care. Furthermore, patient willingness to take a probiotic supplement concomitantly with antibiotics has not been explored. We aimed to conduct an exploratory study using probiotics in adults requiring an acute course of antibiotic therapy.
Methods Patients prescribed antibiotics for treatment of acute infections in an outpatient family practice setting were randomized to receive either a probiotic or placebo concurrently. Patients completed adherence diaries and daily symptom checklists to assess gastrointestinal and vaginal (women) symptoms and collect information about adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults 18 - 79 years of age with infection requiring an oral antibiotic.
- •Must be able to be contacted via telephone.
排除标准
- •pregnancy,
- •breast-feeding,
- •those receiving tube feeding,
- •those with diarrhea as a current symptom of present illness, and pre-existing illnesses that contribute to diarrhea such as inflammatory bowel disease,
- •irritable bowel syndrome, colitis or celiac disease.
- •Those undergoing active cancer treatments with chemotherapeutic or radiation therapy,
- •immunocompromised persons,
- •history of cardiac valvular disease,
- •those taking a laxative or stool softener on a daily basis, as well as
- •persons treated with an antibiotic in the previous 60 days,
- •new antibiotic prescription that exceeds a 10 day course, or regular use of a probiotic within the previous three weeks (including daily ingestion of yogurt).
研究组 & 干预措施
Placebo
Participants are provided in double blinded fashion, Look alike placebo given to take with antibiotics prescribed by their provider.
干预措施: Probiotic (Dietary Supplement)
Probiotic
Participants are provided in double blinded fashion, probiotic given to take with antibiotics prescribed by their provider.
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Rate of antibiotic associated diarrhea
时间窗: two weeks after start of antibiotics
Groups will be compared based on rates of antibiotic associated diarrhea, symptoms developing in the two week window of when antibiotics are started.
次要结局
- Participant knowledge of probiotics(At participant recruitment)
研究者
William Curry
Professor, Family and Community Medicine
Milton S. Hershey Medical Center