Safety of Lactobacillus Reuteri in Healthy Children Ages 2 to 5 Years in Peru
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants With Positive Blood Culture for L Reuteri
研究概览
简要总结
This is a Phase 1 study to assess the safety and tolerability of Lactobacillus reuteri (Lr) strain DSM 17938 in healthy children in Peru. It is a preliminary study in support of a clinical trial to assess safety and efficacy of L. reuteri for treatment of pediatric diarrhea in Peru.
详细描述
This is a phase I blinded randomized study of the safety and tolerability of Lactobacillus reuteri DSM 17938 given daily for a period of five consecutive days. Upon enrollment subjects will be randomized to one of two treatment groups in a ratio of treatment to placebo of 2:1. Subjects will be randomized to receive either:
A. Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).
B. Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).
In the first 30 subjects randomized, administration of each dose of the study preparation drops (A or B above) will be immediately followed by offering 2 ounces of flavored PediaSure ® (Abbott Laboratories) nutritional supplement to each child. The second 30 subjects enrolled will not be offered PediaSure ® after product administration. This format will also allow us to assess the impact of concurrent administration of a buffering non-lactose containing formula with prebiotic nutritional properties on intestinal colonization with L. reuteri by PCR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children ages 2-5 years with no exclusion criteria
排除标准
- •No enrollment of family members in households where any of the following are present:
- •Another study participant in the household
- •Pregnancy or current breastfeeding by any household member
- •Presence of an infant under age 6 months living in the household
- •Presence of immune suppressed individuals or use of immunosuppressive agents (including but not limited to corticosteroids and methotrexate, etc.) by any household member
- •Presence of a serious congenital anomaly or chronic medical condition that in the opinion of the investigators would contraindicate participation in any household member, including history of gastrointestinal surgery, chronic gastrointestinal illness, abnormal intestinal anatomy, or abnormal bowel functionality
- •Allergy to penicillin or cephalosporins or gentamicin 3) History of antibiotic use in the last 30 days 4) Use of probiotic products within the past 90 days, including masato (local product with fermenting bacteria) and yogurt products containing live bacterial cultures.
- •History of diarrheal illness within the past 30 days 6) Presence of fever or a pre-existing adverse event monitored in the study 7) Positive results on serum diagnostic tests for antibodies to HIV.
- •Testing for Hepatitis B core antigen, and Hepatitis C is not necessary in children as in adults, since there is universal vaccination for Hepatitis B among children in this community, and both forms of hepatitis are rare and largely asymptomatic in this age group.
- •Presence of severe anemia, defined as serum hemoglobin < 8 gm/dL
- •Out of range laboratory values for tests monitored as potential adverse events, as described in Appendix 2, B. LABORATORY VALUES, and detected based on Day 0 blood test results. However, subjects will only be excluded based on serum hemoglobin if they meet exclusion criterion
- •Pre-enrollment stool sample (collected within 14 days of Day 1 of the study) is positive for L. reuteri by PCR.
结局指标
主要结局
Number of Participants With Positive Blood Culture for L Reuteri
时间窗: Participants are followed an average of 36 days
Mean Daily Temperature
时间窗: Study days 1-5, 8,12, 15, 18, 28, and 36
Mean of body temperatures recorded on study days listed, averaged across all participants at all time points
次要结局
未报告次要终点
研究者
Richard A. Oberhelman
Professor
Tulane University School of Medicine