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

B.Infantis 35624 in Patients With Mild to Moderate Chronic Plaque Psoriasis -a Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Dietary supplement: B. Infantis 35624

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland
    • Alimentary Health Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo sachets contained 5 grams of Maltodextrin only.	Dietary supplement: B. Infantis 35624; One sachet daily for 12 weeks
Experimental: B Infantis 35624; Each 5gram freeze-dried powder contained ≥1*1010 Colony forming units (CFU) of B. infantis 35624/sachet.	Dietary supplement: B. Infantis 35624; One sachet daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Psoriasis area and severity index between baseline and end of feeding	The PASI score stands for Psoriasis Area and Severity Index. This tool allows researchers to put an objective number on what would otherwise be a very subjective idea: how bad is a person's psoriasis. To make up the score, the three features of a psoriatic plaque (redness) scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. Then the extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72	At 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis Disability Index[PDI}	The Psoriasis Disability Index questionnaire is designed for use in adults, i.e. patients over the age of 16. It is self explanatory and can be handed to the patient who is asked to fill it in without the need for a detailed explanation. It is usually completed in three or four minutes. There are two possible alternative formats of the PDI. One uses visual analogue scales for each answer, the other uses tick box choices for each answer	at 12 weeks

Collaborators and Investigators

• Sponsor: Alimentary Health Ltd
• Collaborators: Whately-Smith Ltd, King's Langley,UK
• Investigators: Study Director: Liam O Mahony, Dr., Alimentary Health Ltd

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: October 3, 2011
• First Submitted That Met QC Criteria: October 12, 2011
• First Posted (Estimate): October 13, 2011

Study Record Updates

• Last Update Posted (Estimate): October 13, 2011
• Last Update Submitted That Met QC Criteria: October 12, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Pilot study
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: Psoriasis Pilot Study; AH-PSR-01 (Registry Identifier: Clinicaltrials.gov)