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

This study has been completed.
Sponsor:
Collaborator:
Whately-Smith Ltd, King's Langley,UK
Information provided by (Responsible Party):
Alimentary Health Ltd
ClinicalTrials.gov Identifier:
NCT01451346
First received: October 3, 2011
Last updated: October 12, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Psoriasis
Dietary Supplement: B. Infantis 35624
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: B.Infantis 35624 in Patients With Mild to Moderate Chronic Plaque Psoriasis -a Pilot Study

Resource links provided by NLM:


Further study details as provided by Alimentary Health Ltd:

Primary Outcome Measures:
  • Change in the Psoriasis area and severity index between baseline and end of feeding [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Psoriasis Disability Index[PDI} [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]

    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



Enrollment: 47
Study Start Date: January 2008
Study Completion Date: August 2011
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451346

Locations
Ireland
Alimentary Health Ltd
Cork, Ireland
Sponsors and Collaborators
Alimentary Health Ltd
Whately-Smith Ltd, King's Langley,UK
Investigators
Study Director: Liam O Mahony, Dr. Alimentary Health Ltd
  More Information

No publications provided

Responsible Party: Alimentary Health Ltd
ClinicalTrials.gov Identifier: NCT01451346     History of Changes
Other Study ID Numbers: Psoriasis Pilot Study, AH-PSR-01
Study First Received: October 3, 2011
Last Updated: October 12, 2011
Health Authority: Ireland: Irish Medicines Board
Ireland: Research Ethics Committee

Keywords provided by Alimentary Health Ltd:
Pilot study

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 28, 2014