Phase 1: Safety of Lactobacillus Reuteri in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Serum AST in Males
研究概览
简要总结
This is a phase one study to assess the safety of daily dosing of Lactobacillus reuteri in healthy adults in Peru. It is conducted as a preliminary study in support of a clinical trial to assess safety and efficacy of Lactobacillus reuteri versus placebo 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).
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18-65 with no exclusion criteria
- •Subject is a male or, if the subject is female and of childbearing potential then she must have a negative serum or urine pregnancy test result within 48 hours of initiating study preparations and agree to use an acceptable method of contraception. Acceptable methods of contraception include depot forms of progesterone containing therapies or an intrauterine device (IUD).
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 (corticosteroids, methotrexate) by any household member
- •Presence of a serious congenital anomaly or chronic medical condition that 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
- •History of antibiotic use in the last 30 days
- •Use of probiotic products within the past 90 days
- •History of diarrheal illness within the past 30 days
- •Presence of fever or a pre-existing adverse event monitored in the study
- •Positive results on serum diagnostic tests for antibodies to HIV, Hepatitis B core antigen, and Hepatitis C.
结局指标
主要结局
Serum AST in Males
时间窗: Day 5
Leukocyte Count on Day 5
时间窗: Measured on day 5
Number of Participants With a Positive Blood Culture for L. Reuteri
时间窗: participants were followed for an average of 36 days
To assess association between administration of Lactobacillus reuteri (Lr) strain DSM 17938 and abnormal lab values (CBC, BUN, Creatinine, AST, ALT, blood culture).
Mean Daily Temperature
时间窗: 5 days of study product administration
Measured daily during 5 days of study product administration
Serum ALT in Males
时间窗: Day 5
Blood Urea Nitrogen
时间窗: Day 5
Serum Aspartate Aminotransferase (AST) in Females
时间窗: Day 5
Serum Alanine Aminotransferase (ALT) in Female Participants
时间窗: Day 5
Serum Creatinine
时间窗: Day 5
次要结局
- Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Vomiting Reported(Day 0 through 6 weeks after Day 0)
- Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Malaise Reported(Day 0 through 6 weeks after Day 0)
- Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Pruritis Reported(Day 0 through 6 weeks after Day 0)
- Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Headache Reported(Day 0 through 6 weeks after Day 0)
- Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Diarrhea Reported(Day 0 through 6 weeks after Day 0)
- Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Subjective Fever Reported(Day 0 through 6 weeks after Day 0)
- Number of Subjects With at Least One PCR Positive Stool Specimen(Average of 36 day follow up period)
- Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Myalgia Reported(Day 0 through 6 weeks after Day 0)
研究者
Richard A. Oberhelman
Professor
Tulane University School of Medicine