Study in Patients With Mild to Moderate Psoriasis

NCT ID: NCT01451346

Last Updated: 2011-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-08-31

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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Placebo sachets contained 5 grams of Maltodextrin only.

Group Type: PLACEBO_COMPARATOR

B. Infantis 35624

Intervention Type: DIETARY_SUPPLEMENT

One sachet daily for 12 weeks

B Infantis 35624

Each 5gram freeze-dried powder contained ≥1\*1010 Colony forming units (CFU) of B. infantis 35624/sachet.

Group Type: EXPERIMENTAL

B. Infantis 35624

Intervention Type: DIETARY_SUPPLEMENT

One sachet daily for 12 weeks

Interventions

B. Infantis 35624

One sachet daily for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Whately-Smith Ltd, King's Langley,UK

UNKNOWN

Sponsor Role: collaborator

Alimentary Health Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liam O Mahony, Dr.

Role: STUDY_DIRECTOR

Alimentary Health Ltd

Locations

Alimentary Health Ltd

Cork, , Ireland

Countries

Ireland

Other Identifiers

AH-PSR-01

Identifier Type: REGISTRY

Identifier Source: secondary_id

Psoriasis Pilot Study

Identifier Type: -

Identifier Source: org_study_id