EUCTR2009-010713-69-SI进行中（未招募）不适用
Randomized, placebo controlled, double-blind, parallel group, multicentric Phase IV study on the clinical efficacy of lactic acid bacteria in form of hard capsules (capsule contains not less than 2 x 109 CFU of liophilisated lactic acid bacteria Lactobacillus acidophilus (LA-5) and Bifidobacterium animalis subsp. lactis (BB-12) in ration 1:1) as prevention of antibiotic associated acute diarrhea in adults.
ek Pharmaceuticals d.d.0 个研究点目标入组 200 人开始时间: 2009年4月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Age between ?18 to 70; male or female
- •2.Subject has been prescribed antibiotic therapy for the duration of at least 7 days to 2 weeks at baseline visit (amoxicillin-clavulanate)
- •3.Willing to consult with study doctor before any new drug would be taken during the course of their participation
- •4.Willing not to consume any products containing probiotics during participation in the clinical trial (see Appendix 3)
- •5.Willing to complete diary card during participation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Hypersensitivity to any of the ingredients or excipients:
- •anhydrous glucose, microcrystal cellulose, potato starch, inulin, oligofructose (glucose, fructose, saccharose), magnesium stearat, hypromellose, titanium dioxide (E171), yellow iron oxide (E172)
- •2. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorbtion or sucrase-isomaltase insufficiency
- •3. Allergy to milk proteins
- •4. Pregnancy or lactation
- •5.Females of child-bearing potential not using effective contraception, i.e. oral contraception/intrauterine device and/or condoms
- •6. Immunocompromised patients
- •7. Unwilling or incapable to give written informed consent or to comply with study directives
- •8. Patients with diarrhea on entry or within the preceding week
- •9. Patients with diagnosis of irritable bowel syndrom, Chron disease, bowel pathology that could result in diarrhea
- •10. Current use of medication is in accordance with the criteria listed in Section 3.4.1.3. (Prohibited medication: Butilscopolamine (Buscopan), metoklopramid (Reglan), domperidon (Tametil), bisakodil (Dulcolax, Novolax), lactulose (Lactecon, Portalac, Prorektal S), lactitol (Importal), glycerol (glycerin globulae))
- •11. Use of antibiotic in the previous two weeks
研究者
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