Mild to moderate psoriasis
Conditions
Interventions
Product Name: Bifidobacterium
Product Code: 35624
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Alimentary Health Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects diagnosed with mild to moderate psoriasis as defined by the clinician 2. Has a Psoriasis Area and Severity Index{PSAI} of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Are less than 18 years of age, and not more than 60 years of age. 2. History of sensitivity to lactose (e.g., lactose intolerance) or other dairy products; 3. Pregnant or lactating females. 4. Consume other probiotics within 2 weeks of treatment start 5. Being treated with steroids 2 weeks prior to entry 6. Evidence of other inflammatory skin disease that may confound the evaluation of psoriasis. 7. Has had systemic antipsoriatic treatment or PUVA therapy within the previous 4 weeks. 8. Subject who has had UVB therapy within the previous 2 weeks. 9. Diseases of the gastrointestinal tract, liver, pancreas and bilary tree [e.g. gastritis, symptomatic gallstones, duodenal ulcer, gastroenteritis, diverticulitis]. Exceptions include haemorrhoids, hiatus hernia and asymptomatic gallstones. 10. History of major gastric, hepatic, pancreatic or intestinal surgery or perforation, excluding cholecystectomy, appendectomy, haemorrhoidectomy or polypectomy. 11. Recent unexplained rectal bleeding and/or significant unexplained weight loss. 12. Antibiotic use within one month prior to Visit 1, 13. Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, immunological,) or a condition, which contraindicates, in the investigators judgement, entry to the study. 14. Patients with Diabetes Mellitus. 15. 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. 16. Subjects currently receiving treatment involving experimental drugs. 17. If a subject has been in a recent experimental trial, must be not less than 30 days prior to this study. 18. Have a concomitant end-stage organ disease eg, cardiovascular, pulmonary, hepatic and renal, which, in the Investigator’s judgment, contraindicates participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Change in the Psoriasis area and severity index between baseline and end of feeding.;Secondary Objective: The secondary end point= Psoriasis Disability Index{PDI} Patients Global Assessment,{PGA} Physician,s Global Assessment Index.{PGAI} ;Primary end point(s): Primary efficacy endpoint = Change in the Psoriasis area and severity index between baseline and end of feeding. | — |
Countries
Ireland
Outcome results
None listed