Study in Patients With Mild to Moderate Psoriasis (AH-PSR-01)

Alimentary Health Ltd

Status and phase

Completed

Phase 2

Phase 1

Conditions

Psoriasis

Treatments

Dietary Supplement: B. Infantis 35624

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT01451346

Psoriasis Pilot Study

AH-PSR-01 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

47 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.