ABOUT THIS STUDY
1. Males and females 18 years of age and older.
2. Clinical diagnosis of psoriasis for at least 6 months as determined by subject interview of his/her medical history and confirmation of diagnosis through physical examination by Investigator.
3. Stable plaque psoriasis for at least 2 months before Screening and at Baseline (Week 1) as determined by subject interview of his/her medical history.
4. Subject is a candidate for phototherapy.
5. Subject has at least one psoriatic plaque measuring at least 6cm x 2cm located on either the arms or the legs (excluding intertriginous areas such as the axilla and inguinal folds)
6. Able and willing to give written informed consent and to comply with requirements of this study protocol.
1. Subject has photosensitizing condition or other contraindication to phototherapy
2. Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis,
medication-induced or medication-exacerbated psoriasis, or new onset guttate
3. Cannot discontinue or avoid topical therapies for psoriasis for at least 14 days prior
to the Baseline (Week 1) visit and during the study other than on face, underarms, or
4. Cannot discontinue or avoid UVB phototherapy or Excimer laser for at least 14 days
prior to the Baseline (Week 1) visit.
5. Subject is receiving therapy for psoriasis that requires a wash out period of more
than 14 days (e.g., psoralen-UVA phototherapy, oral systemic therapy, biologic
therapy, or other investigational therapy).
6. Other active inflammatory dermatologic conditions (e.g., eczema) or presence of
pustular or erythrodermic psoriasis.
7. Any history of acute or chronic bacterial, fungal, or viral infection (including HIV,
hepatitis, tuberculosis, or other severe or recurrent infections) within 30 days of
baseline sample collection.
8. Subject has used systemic (oral or parenteral) antibiotic, antimycotic, or antiviral
within 3 months or topical antibiotic, antimycotic, or antiviral within 14 days of
baseline sample collection or requires use of any topical or systemic antibiotic,
antimycotic, or antiviral during the study.
9. Consumption of large doses of commercial probiotics (greater than or equal to 108 cfu
or organisms per day) including tablets, capsules, lozenges, chewing gum or powders in
which probiotic is a primary component. Ordinary dietary components such as fermented
beverages/milks, yogurts, and foods do not apply.
10. Presence of comorbid medical condition (e.g., HIV, malignancy within past 5 years
other than successfully treated basal cell carcinoma, non-metastatic cutaneous
squamous cell carcinoma or cervical carcinoma in-situ) that significantly alters the
immune system or results in immunosuppression.
11. Subject is taking (within up to 180 days of baseline sample collection) or requires
topical or systemic therapy during the study that significantly alters the immune
system or results in immunosuppression (e.g., chemotherapy, oral or injectable
corticosteroid). Inhaled corticosteroids for stable medical conditions are allowed.
12. Unstable dietary history as defined by major changes in diet within 30 days of
baseline or during study, where the subject has or plans to eliminate or significantly
increase major food group in the diet.
13. Recent history of substance abuse or psychiatric illness that could preclude
compliance with the protocol.
14. History of any substance abuse within 365 days of screening visit.
15. Female subject who is pregnant or breast-feeding or considering becoming pregnant
during the study.
16. Major surgery of the gastrointestinal tract, with the exception of cholecystectomy and
appendectomy, in the past 5 years. Any major bowel resection at any time.
17. History of active uncontrolled gastrointestinal disorders or diseases including:
- Inflammatory bowel disease including ulcerative colitis, Crohn's disease, or
- Irritable bowel syndrome;
- Persistent, infectious gastroenteritis, colitis, or gastritis, persistent or
chronic diarrhea or unknown etiology, Clostridium difficile infection (recurrent)
or Helicobacter pylori infection (untreated).
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