Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Adults on Antibiotics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The primary outcome is to assess the safety of BB-12 yogurt when consumed by generally healthy adults who are consuming antibiotics.
研究概览
简要总结
We believe a readily available drink containing a high dose of probiotics has the potential to improve compliance through many of these mechanisms. This product also has the potential to positively impact the health of children and adults around the world, as yogurt will likely be more appealing to both children and their parents for long term consumption than pharmaceutical-like preparations. In addition to the benefits associated with the consumption of probiotics, there is an increased health benefit from consuming yogurt, a nutrient dense food.
More specifically, the rationale for this Phase I study is to determine safety of our drink and comply with the FDA's recommendations pertaining to an IND application, we will conduct a phase I safety study.
We hypothesize that BB-12 is safe in healthy adults ages 18 and over.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to speak and write English or Spanish
- •Refrigerator for proper storage of drink
- •Telephone access
- •Enrollment must take place within 24 hours of starting antibiotics
- •Treatment with a penicillin class antibiotic regimen for 10 days for an upper respiratory infection;
- •The following is a list 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)
- •Antibiotic prescribed at least twice a day
- •Outpatients
排除标准
- •Chronic conditions, such as diabetes or asthma, that require daily medication
- •Allergy to strawberry
- •Active diarrhea
- •Allergy to penicillin class antibiotic
- •Any other medicines used except prescribed antibiotic and anti-pyretic medicines
- •Allergy to any of the following medications
- •Tetracycline
- •Erythromycin
- •Trimethoprim
- •Ciprofloxacin
- •Lactose intolerance.
- •During baseline physical exam, any of the following will be grounds for exclusion; systolic blood pressure>140, systolic blood pressure <90, diastolic >90, oxygen saturation <98%, pulse rate >100, pulse rate <55 and respiratory rate >
- •These include all vital signs that fall outside of the "normal" range, including Grade 1 through Grade 4.
研究组 & 干预措施
1. Active
Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12)
Probiotic, BB-12, supplemented yogurt, 4 ounces taken orally for 10 days
干预措施: Bifidobacterium animalis subsp. lactis strain BB-12 (Drug)
2. Placebo
Strawberry flavored yogurt
干预措施: Placebo (Drug)
结局指标
主要结局
The primary outcome is to assess the safety of BB-12 yogurt when consumed by generally healthy adults who are consuming antibiotics.
时间窗: 1 year
次要结局
- In addition to safety diary, participants will keep a daily diary to track number of bowel movements, if drink was consumed, if illness resulted in change in activity, over-the-counter medicines used and other illness symptoms.(1 year)
研究者
Daniel Merenstein
Principal Investigator
Georgetown University