Is the Human Microbiome Altered in Patients With Axial Sp... | NCT02962479

Studies
Is the Human Microbiome Altered in Patients With Axial Spondyloarthritis?

NCT02962479

Sponsor

Eyal Kedar

Status

Unknown status

Last Update Posted

Nov 11, 2016Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Axial Spondyloarthritis
Ankylosing Spondylitis

Interventions

Not provided

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

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Oct 2017Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

Nov 8, 2016

First Submission Date that Met QC Criteria

Nov 9, 2016

First Posted Date

Nov 11, 2016Estimated

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

Nov 9, 2016

Last Update Posted Date

Nov 11, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to compare biological communities in stool samples obtained from age, diet and BMI-matched subjects in five study groups: subjects with ankylosing spondylitis (AS) never treated with tumor necrosing factor (TNF) inhibitors, subjects with ankylosing spondylitis previously or currently treated with TNF inhibitors, subjects with non-radiographic axial spondyloarthritis (nrSpA) never treated with tumor necrosing factor (TNF) inhibitors, subjects with non-radiographic axial spondyloarthritis previously or currently treated with TNF inhibitors and healthy participants.

The differences in fecal microbiota composition will be explored using shotgun metagenomic sequencing through the University of Washington. The investigators predict that this study will confirm a significant difference between the fecal microbiota composition (FMC) of both AS and nrSpA patients and controls.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Measure	Description	Time Frame
Weighted and unweighted UniFrac distances between stool samples from the five study groups		Within 1 month of baseline visit

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able to provide informed consent
Male or Female patients ≥18 years of age
Additional Inclusion Criteria based on cohort

Exclusion Criteria:

Current use of any pain-relieving medications other than NSAIDs, APAP and/or opioids
Corticosteroid therapy or probiotic exposure within the last two weeks
Antibiotic exposure within the past two months
History of psoriasis or inflammatory bowel disease or reactive arthritis or any other chronic rheumatologic disease
Active infection
History of hepatitis B or C or HIV
Active cancer or history of colon cancer or any form of chemotherapy or radiation within the past year
Celiac disease
Use of proton pump inhibitors within the prior two months
History of clostridium difficile
Pregnancy
Active diarrhea (defined as a decrease in fecal consistency lasting four or more weeks)
Additional Exclusion Criteria based on cohort

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

At least 50 subjects, male and female, aged 18 or older, will be recruited to the study and assigned to one of five groups:

Ten TNF blocker-naïve ankylosing spondylitis patients
Ten TNF blocker-exposed ankylosing spondylitis patients
Ten TNF blocker-naïve nrSpA patietns
Ten TNF blocker-exposed nrSpA patients
Ten healthy age, diet and BMI-matched controls Inclusion and exclusion criteria will vary by study group. It is anticipated that the TNF-blocker naïve groups will be the most difficult to recruit, so these groups will serve as the baseline for age and diet matching for the other two groups. Up to seventy (70) additional TNF-treated axial SpA and healthy subjects may be asked to complete the dietary questionnaire, but will not provide stool samples unless age, diet and BMI-matched with a TNF-blocker-naïve axial SpA subject.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
St. Lawrence Health System		Potsdam	New York	13676	United States

ID	Term
D000089183	Axial Spondyloarthritis
D013167	Spondylitis, Ankylosing

ID	Term
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases

Description

Subjects will have the option to provide additional consent for specimens to be retained by the research team indefinitely for research purposes. These samples will be identified only by the numeric study ID; no personally identifying information will be associated with the retained samples. The samples could be used to make new products, tests or findings, which may have value and may be developed and owned by the research team and/or others. Investigators will not be able to provide subjects with results from any future research that is done using their samples.

Label	Type	Description	Intervention Names
TNF blocker-naïve ankylosing spondylitis patients
TNF blocker-exposed ankylosing spondylitis patients
TNF blocker-naïve nrSpA patients
TNF blocker-exposed nrSpA patients
Healthy Participants