Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing Diarrhea
研究概览
简要总结
Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. One of the most common indications for probiotic treatment is the prevention of antibiotic-associated diarrhea (AAD). Unfortunately, many probiotic products used for AAD are not supported by rigorous independent research, and often results in non-evidence-based usage. The overarching objective is to move research forward for the most well-studied Bifidobacterium strain. The primary aim is to test the efficacy of high dose, BB-12-supplemented yogurt in preventing AAD, compared to yogurt without BB-12, in children receiving antibiotics. Other aims are to further assess the safety of yogurt supplemented with BB-12, and to carry out longitudinal community structure and gene expression analysis of fecal microbiota to evaluate the impact of high dose BB-12 in a pediatric population receiving antibiotics. The microbiota includes hundreds of species, and its disruption is hypothesized to be an important factor in the development of AAD.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child is between ages of 3-12 years
- •Caregiver has the ability to read, speak and write English or Spanish
- •Household has refrigerator for proper storage of drink
- •Household has telephone access
- •Enrollment must take place within 24 hours of starting antibiotics
- •Child was outpatient treated
- •Child was prescribed treatment with a penicillin or cephalosporin class antibiotic regimen for 7-10 days for a respiratory infection;
- •The following is a list (non-exhaustive) of inclusive antibiotics:
- •Amoxicillin
- •Augmentin (amoxicillin/clavulanate)
- •Ancef (cefazolin)
- •Duricef (cefadroxil)
- •Keflex (cephalexin)
- •Kefzol (cefazolin)
- •Velosef (cephradine)
- •Ceclor (cefaclor)
- •Ceftin (cefuroxime)
- •Cefzil (cefprozil)
- •Lorabid (loracarbef)
- •Mefoxin (Cefoxitin)
- •Zinacef (cefuroxime)
- •Omnicef (cefdinir)
- •Suprax (cefixime)
- •Dicloxacillin
- •Pen-Vee K (penicillin)
排除标准
- •Developmental delays
- •Any chronic condition, such as diabetes or asthma, that requires medication
- •Prematurity, or born prior to 37 weeks gestation/of pregnancy
- •Congenital anomalies
- •Failure to thrive
- •Allergy to strawberry
- •Active diarrhea (diarrhea is defined in this study as three or more loose stools per day for two consecutive days)
- •Any other medicines used except anti-pyretic medicines (pro re nata concomitant medications are allowed)
- •Parental belief of lactose intolerance
- •History of heart disease, including valvulopathies or cardiac surgery, any implantable device or prosthetic
- •History of gastrointestinal surgery or disease
- •Milk-protein allergy
- •Allergy to any component of the product or the yogurt vehicle
- •Allergy or a hypersensitivity to the antibiotic prescribed by her/his provider
- •Allergy to any of the following medications:
- •Tetracycline
- •Erythromycin
- •Trimethoprim
- •Ciprofloxacin
- •blood oxygen saturation is less than 90% (if enrollment/baseline visit is completed in person and if the participant was prescribed antibiotics during a telemedicine visit)
研究组 & 干预措施
BB-12
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt
干预措施: Bifidobacterium animalis subsp. lactis BB-12 (Biological)
Control
Yogurt without Bifidobacterium animalis subsp. lactis BB-12
干预措施: Control (Other)
结局指标
主要结局
Number of Participants Experiencing Diarrhea
时间窗: 14 days
Diarrhea is clinically defined as three or more loose stools per day for two consecutive days. This will be a dichotomous (yes or no) outcome of diarrhea.
Adverse Events
时间窗: Days 0-180
Number of reported adverse events over the duration of the study
次要结局
- Pediatric Quality-of-life Score(7 days)
- Number of Events: Symptoms of Loose Stools, Constipation, Fever, Flatulence, Lack of Appetite, Pain, Rash, Vomiting, Cough, Earache, Nasal Congestion, Runny Nose, Sore Throat, Diarrhea.(14 days)
研究者
Daniel Merenstein
Professor and Director of Research Programs
Georgetown University