THE IMPACT OF GI HEALTH ON JOINTS: A CLINICAL STUDY

February 2, 2023 arosari

Principal Investigator

Description

We are excited to update you on the progress of our clinical study. Due to overwhelming interest and participation, we have temporarily paused enrollment to ensure the highest quality of care and attention to each participant.

We anticipate resuming enrollment in late July and encourage you to stay tuned for an immediate update on our website once we are ready to start back up again. Your enthusiasm and support for our study are greatly appreciated, and we are committed to keeping you informed every step of the way, and look forward to welcoming new participants and continuing our important research together.

NC State University College of Veterinary Medicine is seeking dogs with or without mobility problems that are 5 years of age or older and weigh at least 10 kg to take part in a study aiming to evaluate the relationship between intestinal permeability and multiple joint osteoarthritis.

Eligibility

To be eligible for the first 2-3 visits of the study, your dog must meet the following requirements:

• Weighs ≥10 kg (22 pounds)
• Is ≥ 5 years of age
• Be able to comfortably cease NSAIDS — if taking any — for 7 consecutive days prior to the second study visit day in Aim I
• Be healthy enough to receive moderate sedation

To continue further into Aim 2 after the initial two visits, your dog must have osteoarthritis.

clinical trial dog participants

Testing Requirements

This study has two main visits, with up to three (3) opportunities to participate in afterwards

Initial two-week Participation – Aim 1 (all dogs): Characterizing (phenotyping) your dog
- Two visits total over 14 days
- Your dog will receive:
  - X-rays of every joint in the body
  - Comprehensive bloodwork and urinalysis
  - Physical, orthopedic, and neurologic examinations
  - Measurement of intestinal permeability using a protocol that involves oral administration of a contrast agent and followed by blood collection
- On completion of Aim 1, you will receive a $50 “thank you” gift card
- Additionally, you will earn a $50 Amazon gift card by scheduling a separate 1-2 hour visit after enrolling in Aim I. We contact you to arrange the details after enrollment! During the visit, your dog will enjoy soothing music, belly rubs, and a comfortable room to relax in. We test their reaction time from this tranquil state. No fasting, questionnaires, or additional tasks! Bring familiar items from home to help your dog feel at ease. Don’t miss out on this opportunity!
- A select few dogs will be offered to participate in colonic endoscopy and biopsies after finishing this Aim. You will receive a $200 “thank you” gift card if you choose to include your dog in this subset.

Continued 8-month Participation – Aim 2 (dogs with OA): Monitoring the progression of your dog’s OA over 8-months
- There are 5 visits total in Aim II. Visits occur every two months until the final two visits, which mirror the dog’s initial two-week participation of Aim 1. Although the final two visits are drop-off visits, like in Aim I, the rest of the visits are only 1-2 hour rechecks.
- Your dog will receive:
  - X-rays of every joint in the body
  - Comprehensive bloodwork and urinalysis
  - Physical, orthopedic, and neurologic examinations
  - Measurement of intestinal permeability as described above
- On completion of Aim 2, you will receive a $150 “thank you” gift card

For all parts of the study, dogs will need to wear a ‘fit bit’ like device attached to their collar to measure their activity.

All dogs must complete both visits of Aim 1 first if they are included in the study. The initial visit of the study (the first visit of Aim 1) includes a 30 minute meet-and-greet in a quiet room prior to dropping the dog off for the day; this is to acclimate the dog to the new environment, and for owners to be introduced to the study questionnaires they will fill out each visit. After the first two visits, owners will then have the opportunity to participate in Aim 2 if their dog has radiographic evidence of arthritis.

Clinical study map

Enrollment Start

03/01/2023

Enrollment Finish

12/31/2025