PER-034-17尚未招募未知
ACTOBACILLUS REUTERI DSM 17938 PHASE 1 DOUBLE-BLIND PLACEBO-CONTROLLED SINGLE-TRIAL STUDY IN CHILDREN AGED 2-24 MONTHS
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Have a parental permission form signed by both parents
- •Be between 8 weeks to 24 months of age with no preexisting exclusion criteria
- •Have parents who are willing to comply with all planned study procedures and be available for planned study visits for 3 months.
排除标准
- •The following risk factors are at the level of the individual child:
- •2) Allergy to penicillin, cephalosporins, clindamycin or gentamicin
- •3)History of antibiotic use in the last 30 days
- •4)Use of probiotic products within the past 30 days, including masato (local product with fermenting bacteria) and yogurt products containing live bacterial cultures.
- •5) History of diarrheal illness within the past 30 days (See definition in Protocol Appendix B)
- •6) Presence of fever or a pre-existing adverse event monitored in the study (See Protocol Appendix B Definitions of AEs for specific adverse events monitored in the study)
- •7) Positive results on serum diagnostic tests for antibodies to HIV.
- •8)Presence of severe anemia, defined as serum hemoglobin < 7 gm/dL
- •9)Out of range laboratory values for total leucocyte count, BUN, Creatinine, AST, ALT, and total bilirubin monitored as potential adverse events, as described in Appendix E.
- •10)Pre-enrollment stool sample (collected within 14 days of day 1 of the study) is positive for L. reuteri by PCR.
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