Status:
COMPLETED
Study in Patients With Mild to Moderate Psoriasis
Lead Sponsor:
Alimentary Health Ltd
Collaborating Sponsors:
Whately-Smith Ltd, King's Langley,UK
Conditions:
Psoriasis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01451346
Start Date
January 1 2008
End Date
August 1 2011
Last Update
October 13 2011
Active Locations (1)
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1
Alimentary Health Ltd
Cork, Ireland