Patterns After Administration of MCFAs in Psoriasis and P... | NCT03409211

Studies
Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis

NCT03409211

Sponsor

NYU Langone Health

Status

Completed

Last Update Posted

Dec 2, 2020Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Psoriasis
Psoriatic Arthritis

Interventions

PEVCO
Dietary Supplement Capsules without Coconut Oil

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2017Actual

Primary Completion Date

Sep 30, 2019Actual

Completion Date

Sep 30, 2019Actual

First Submitted Date

Jan 5, 2018

First Submission Date that Met QC Criteria

Jan 23, 2018

First Posted Date

Jan 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2020

Last Update Posted Date

Dec 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pso	Active Comparator	with or without PsA	Dietary Supplement: PEVCO Dietary Supplement: Dietary Supplement Capsules without Coconut Oil
Healthy Subjects	Active Comparator	Without PsA	Dietary Supplement: PEVCO Dietary Supplement: Dietary Supplement Capsules without Coconut Oil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PEVCO	Dietary Supplement	All subjects will receive PEVCO for 6 more weeks.	Healthy Subjects Pso

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)](streamdown:incomplete-link)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jose Scher, MD	NYU Langone Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York University School of Medicine		New York	New York	10016	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011565	Psoriasis
D015535	Arthritis, Psoriatic

Ancestor Terms

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D025242	Spondylarthropathies

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000074263	Coconut Oil
D019587	Dietary Supplements

Ancestor Terms

ID	Term
D004041	Dietary Fats
D005223	Fats
D008055	Lipids
D010938	Plant Oils
D009821

Browse Leaves

Not provided

Browse Branches

Not provided