Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis

Study Overview
=================
Brief Summary
-----------------
This is a proof-of-principle, placebo-controlled, open label study to assess the improvement in the Treg counts and PASI Scores with PEVCO given at 1000 mg four times daily in patients with PsO (subjects may or may not have PsA) , who have active disease and are not currently receiving other therapy (as defined by the inclusion/exclusion criteria) compared to healthy subjects. The patients and healthy controls will receive placebo or PEVCO for a total of 9 weeks (3 weeks for placebo, followed by 6 weeks for PEVCO). No topical or systemic medications will be used during this period.

Official Title
-----------------
Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis

Conditions
-----------------
Psoriasis, Psoriatic Arthritis

Intervention / Treatment
-----------------
* Dietary Supplement: PEVCO
* Dietary Supplement: Dietary Supplement Capsules without Coconut Oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have an active [psoriatric plaque >2cm Exclusion Criteria: History of sensitivity to study compound or any of their excipients Previous intolerance to PEVCO or related compounds Current (within 3 months of screening) treatment with DMARDs Current (within 3 months of screening) treatment with biologic therapies (including but limited to anti-TNF,anti-IL-17, anti-IL-12/23) Current antibiotic treatment (within 3 months of screening) current consumption of probiotics (within 3 months of screening) Severe hepatic impairment (eg, ac-sites and/or clinical signs of coagulopathy) Renal failure (eGFR ,30 or require dialysis) by history History of other autoimmune or inflammatory skin disease Current immunodeficiency state (cancer, HIV, others) Current immunodeficiency state (cancer, HIV, Other) Concern for inability of the patient to comply with study procedure, and or follow up (alcohol or drug abuse)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pso<br>with or without PsA | Dietary Supplement: PEVCO<br>* All subjects will receive PEVCO for 6 more weeks.<br>* Other names: Coconut Oil;Dietary Supplement: Dietary Supplement Capsules without Coconut Oil<br>* All subjects will receive placebo (PBO) for 3 weeks<br>|
| Active Comparator: Healthy Subjects<br>Without PsA | Dietary Supplement: PEVCO<br>* All subjects will receive PEVCO for 6 more weeks.<br>* Other names: Coconut Oil;Dietary Supplement: Dietary Supplement Capsules without Coconut Oil<br>* All subjects will receive placebo (PBO) for 3 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in % of Treg Cells in Blood | % change in the expansion of regulatory T cells; demonstrate an increase in %Treg at 6 weeks. | 6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in Medium Chain Fatty Acids (MCFA) content in the stool | Change in the amount of MCFA in stool | 12 Weeks | 
| Improvement in skin disease severity PASI scores 50 | indicating 50% reduction in psoriasis | 12 Weeks | 
| Improvement in skin disease severity PASI scores 75 | indicating 75% reduction in psoriasis | 12 Weeks | 
| Improvement in skin disease severity PASI scores 90 | indicating 90% reduction in psoriasis | 12 Weeks | 
| Improvement in the tender joint/swollen joint (TJ/SJ) counts at 6 weeks. | To assess whether PEVCO 1000 mg four times daily for 6 weeks improves: 66/68 Tender-joint count 66/68 Swollen-joint count | 6 Weeks |