EUCTR2007-003951-35-IE进行中（未招募）不适用
/A - Na
Alimentary Health Ltd0 个研究点目标入组 60 人开始时间: 2007年7月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Subjects diagnosed with mild to moderate psoriasis as defined by the clinician
- •2.Has a Psoriasis Area and Severity Index{PSAI} of < than 20.
- •3.Male or Female subjects
- •4.Aged between 18-60 years of age
- •5.Non-pregnant Female and must be agree to use adequate method of contraception during the study
- •6.Is capable of giving written informed consent prior to study entry.
- •7.Be willing to refrain from taking dietary supplements or other foods that contain fermented live bacteria within 1 month prior to treatment and during the study.
- •8.Have not participated in a clinical drug study or used an investigational new drug during the past previous 30 days.
- •9.Clinical chemistry and haematology results from Visit 1 are within normal limits.
- •10.Be willing to refrain from using any topical psoriatic cream 2 weeks prior to treatment and during the study.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Are less than 18 years of age, and not more than 60 years of age.
- •2.History of sensitivity to lactose (e.g., lactose intolerance) or other dairy products;
- •3.Pregnant or lactating females.
- •4.Consume other probiotics within 2 weeks of treatment start
- •5.Being treated with steroids 2 weeks prior to entry
- •6.Evidence of other inflammatory skin disease that may confound the evaluation of psoriasis.
- •7.Has had systemic antipsoriatic treatment or PUVA therapy within the previous 4 weeks.
- •8.Subject who has had UVB therapy within the previous 2 weeks.
- •9.Diseases of the gastrointestinal tract, liver, pancreas and bilary tree [e.g. gastritis, symptomatic gallstones, duodenal ulcer, gastroenteritis, diverticulitis]. Exceptions include haemorrhoids, hiatus hernia and asymptomatic gallstones.
- •10.History of major gastric, hepatic, pancreatic or intestinal surgery or perforation, excluding cholecystectomy, appendectomy, haemorrhoidectomy or polypectomy.
- •11.Recent unexplained rectal bleeding and/or significant unexplained weight loss.
- •12.Antibiotic use within one month prior to Visit 1,
- •13.Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, immunological,) or a condition, which contraindicates, in the investigators judgement, entry to the study.
- •14.Patients with Diabetes Mellitus.
- •15.Individuals who, in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial.
- •16.Subjects currently receiving treatment involving experimental drugs.
- •17.If a subject has been in a recent experimental trial, must be not less than 30 days prior to this study.
- •18.Have a concomitant end-stage organ disease eg, cardiovascular, pulmonary, hepatic and renal, which, in the Investigator’s judgment, contraindicates participation in the study.
研究者
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