PER-029-18已完成未知
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
- 已完成
- 入组人数
- 60
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
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •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
- •1) No enrollment of family members in households where any of the following are present:
- •a. Another study participant in the household
- •b. Presence of immune suppressed individuals or use of immunosuppressive agents (including but not limited to corticosteroids, methotrexate, etc.) by any household member
- •c. 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
- •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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