B.Infantis 35624 in Patients With Mild to Moderate Chronic Plaque Psoriasis -a Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Change in the Psoriasis area and severity index between baseline and end of feeding
研究概览
简要总结
This was a randomized, double blind,fixed dose, placebo controlled, parallel-group pilot study to obtain data on size and variance of treatment effects in subjects with mild to moderate Psoriasis.
详细描述
This was a randomized, double blind,fixed dose, placebo controlled, parallel-group pilot study to obtain data on size and variance of treatment effects in subjects with mild to moderate Psoriasis. The target sample size of 60 was selected as a practical figure for recruitment purposes in one centre over 3 months.After a 2 week washout during which only emollients were applied to their psoriasis, patients attended for baseline assessment of psoriasis severity and blood tests.Subjects attended every 4 weeks for 12 weeks for clinical assessment and blood tests.Each patient once eligible{see inclusion & exclusion criteria} was allocated to either active treatment or placebo in identical packing for a total of 12 weeks.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with mild to moderate psoriasis as defined by the clinician,
- •Has a Psoriasis Area and Severity Index{PASI} of less than 20,
- •Male or female subjects,
- •Aged between 18-60 years of age,
- •Non-pregnant female and must agree to use adequate method of contraception during the study,
- •Is capable of giving written informed consent prior to study entry,
- •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,
- •Have not participated in a clinical drug study or used an investigational new drug during the past previous 30 days,
- •Clinical Chemistry and haematology results from Visit 1 are within normal limits,
- •Be willing to refrain from using any topical psoriactic cream 2 weeks prior to treatment and during the study.
排除标准
- •Are less than 18 years of age, and not more than 60 years of age,
- •History of sensitivity to lactose [eg, lactose intolerance] or other dairy products,
- •History of consumption of probiotics,1 month prior to treatment,
- •Being treated with steroids 2 weeks prior to entry, Diseases of the gastrointestinal tract,liver,pancreas and biliary tree[eg;gastritis,symptomatic gall stones,duodenal ulcer,gastroenteritis,diverticulitis.] Exceptions include haemorrhoids,hiatus hernia and asymptomatic gall stones.
- •History of major gastric,hepatic,pancreatic or intestinal surgery or perforation,excluding cholescystectomy,appendicectomy,haemorrhoidectomy or polypectomy.
- •Recent unexplained rectal bleeding and/or significant unexplained weight loss.
- •Antibiotic use within one month prior to Visit
- •have a significant acute or chronic coexisting illness{cardiovascular,gastrointestinal,immunological}or a condition, which contraindicates,in the investigators judgement entry to the study.
- •Patients with Diabetes Mellitus.
- •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.
- •Subjects currently receiving treatment involving experimental drugs.
- •If a subjects has been in a recent experimental trial,must be not less than 30 days prior to this study.
- •Have a concomitant end stage organ disease eg; cardiovascular,hepatic,pulmonary,renal,which , in the Investigators judgement,contraindicates participation in the study.
- •Have a history of malignancy in the past 5 years with the exception of Basal Cell Carcinoma.
- •Evidence of alcohol or drug abuse.
- •Evidence of unstable forms of psoriasis,including guttate, erthrodermic , exfoliative or pustular psoriasis.
- •Evidence of other inflammatory skin disease that may confound the evaluation of psoriasis.
- •Has had systematic antipsoriatic treatment or PUVA therapy within the previous 4 weeks.
- •Subject who has had UVB therapy with the previous 2 weeks.
- •If the subjects scores >20% on the PASI.
结局指标
主要结局
Change in the Psoriasis area and severity index between baseline and end of feeding
时间窗: At 12 weeks
The PASI score stands for Psoriasis Area and Severity Index. This tool allows researchers to put an objective number on what would otherwise be a very subjective idea: how bad is a person's psoriasis. To make up the score, the three features of a psoriatic plaque (redness) scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. Then the extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72
次要结局
- Psoriasis Disability Index[PDI}(at 12 weeks)