Clinical trial NCT01451346: Study in Patients With Mild to Moderate Psoriasis
Official title: B.Infantis 35624 in Patients With Mild to Moderate Chronic Plaque Psoriasis -a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Psoriasis
Keywords: Pilot study
Lead sponsor: Alimentary Health Ltd
Sponsor class: INDUSTRY
Collaborators: name: Whately-Smith Ltd, King's Langley,UK
First posted: 2011-10-13
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 1. 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.

Primary outcomes:
measure: Change in the Psoriasis area and severity index between baseline and end of feeding
timeFrame: At 12 weeks
Secondary outcomes:
measure: Psoriasis Disability Index[PDI}
timeFrame: at 12 weeks
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Alimentary Health Ltd
Study officials:
affiliation: Alimentary Health Ltd
name: Liam O Mahony, Dr.
role: STUDY_DIRECTOR
References: