Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis

Psoriasis Clinical Trial

— PAMPPA  

Official title:

Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03409211
• Other study ID #: 17-00748
• Status: Completed
• Phase: N/A
• Start date: December 12, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: December 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriasis
• Psoriatic Arthritis

Intervention

Dietary Supplement:
• PEVCO
All subjects will receive PEVCO for 6 more weeks.
• Dietary Supplement Capsules without Coconut Oil
All subjects will receive placebo (PBO) for 3 weeks

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Increase in Medium Chain Fatty Acids (MCFA) content in the stool	Change in the amount of MCFA in stool	12 Weeks
Secondary	Improvement in skin disease severity PASI scores 50	indicating 50% reduction in psoriasis	12 Weeks
Secondary	Improvement in skin disease severity PASI scores 75	indicating 75% reduction in psoriasis	12 Weeks
Secondary	Improvement in skin disease severity PASI scores 90	indicating 90% reduction in psoriasis	12 Weeks
Secondary	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