Study in Patients With Mild to Moderate Psoriasis

NCT01451346 | Completed Phase 1 DMC

• 2 other identifiers: Psoriasis Pilot StudyAH-PSR-01
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Pilot study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Psoriasis Disability Index[PDI}

  at 12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo sachets contained 5 grams of Maltodextrin only.

Dietary Supplement: B. Infantis 35624

B Infantis 35624

EXPERIMENTAL

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

Dietary Supplement: B. Infantis 35624

Interventions

B. Infantis 35624 DIETARY_SUPPLEMENT

One sachet daily for 12 weeks

B Infantis 35624; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alimentary Health Ltd: lead
• Whately-Smith Ltd, King's Langley,UK: collaborator

Study Sites (1)

Alimentary Health Ltd

Cork, Ireland

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Liam O Mahony, Dr.

  Alimentary Health Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2011
• First Posted: October 13, 2011
• Study Start: January 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: August 1, 2011
• Last Updated: October 13, 2011

Record last verified: 2011-10

Locations

IE (1)