MedPath

/A

Conditions
Mild to moderate psoriasis
Registration Number
EUCTR2007-003951-35-IE
Lead Sponsor
Alimentary Health Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
60
Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: Change in the Psoriasis area and severity index between baseline and end of feeding.;Secondary Objective: The secondary end point= Psoriasis Disability Index{PDI}<br> Patients Global Assessment,{PGA}<br> Physician,s Global Assessment Index.{PGAI}<br>;Primary end point(s): Primary efficacy endpoint = Change in the Psoriasis area and severity index between baseline and end of feeding.
Secondary Outcome Measures
NameTimeMethod
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