Internal Medicine

Clinical trials for Internal Medicine specialty

  •  Sponsor:  Private Foundation

    CSRC Protocol #: 026-14

    Status: Not currently enrolling

    Description:

    Dogs get a disease of the intestine called inflammatory bowel disease (IBD) in which the normal lining of the intestine is replaced by inflammatory white blood cells. This inflammation results in poor digestion,  often manifesting as diarrhea, vomiting, and weight loss, and in some cases, loss of protein through the feces. This leads to a severe protein deficiency in the body, called a protein losing enteropathy (PLE). PLE is typically an indication of very severe intestinal inflammation and dogs with this condition may not respond well to typical medications used to treat IBD. In addition the PLE itself can cause fatal complications such as edema, fluid in the abdominal cavity, and blood clots. There is a need for new therapies to treat dog with PLE secondary to IBD. Based on evidence in the literature from pre-clinical and clinical trials in humans, we hypothesize that treatment of dogs with a PLE from IBD with stem cells isolated from the umbilical cords of dogs will modulate the inflammatory response in the intestine and induce clinical remission.

    The purpose of the study is to determine whether intravenous administration of cells called mesenchymal stem cells can improve your dog’s clinical signs as well as their blood protein levels. It is believed that the benefit of these stem cells is related to their ability to suppress inflammation.

    Inclusion Criteria:

    Dogs will have had incomplete response to therapy with prednisone, budesonide and/or cyclosporine (defined by a clinical score (CCECAI) >5), have intolerable side effects on medication, or have the administration of cyclosporine or chlorambucil be financially unreasonable for the owner, as these are the patients who require alternative therapeutic options.

    Dogs with biopsy confirmed IBD and bloodwork confirmed panhypoproteinemia

    (total protein <5.5 mg/dl) will be enrolled. The biopsies may be performed at Tufts if they are not already available for pathologist review.

    Both male and female dogs weighing greater than 11 pounds and any age will be considered for the study.

    Exclusion Criteria:

    Dogs with a urine protein:creatinine (UPC) ratio of >0.5, a baseline cortisol < 2 ug/dL, and a post- prandial bile acids of > 30 uM will be excluded from the study. This will eliminate dogs with protein loss through the kidneys, abnormal production of protein from the liver, or Addison’s disease. These tests can be performed at Tufts.

    All dogs will have an abdominal ultrasound and those with signs of intestinal or extra-intestinal masses will be excluded.

    Yorkshire Terriers, Soft-Coated Wheaten Terriers, and Boxers will be excluded, as these dogs have unique IBD features that respond differently from the general population of dogs.

    Dogs with congestive heart failure, Cushing’s disease, diabetes mellitus, or cancer will also be excluded.

    Client Benefits:

    Expenses associated with giving the injection of stem cells and in evaluating your dog after the injection will be covered. Some initial testing, recheck examinations, and follow-up blood work will be covered. Your pet’s participation will also allow us to gain valuable information which will help in the management and treatment of other dogs with this condition.

     

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

  • Status:  Currently enrolling

    Description:

    The purpose of the study is to investigate ways to monitor dogs that have been diagnosed with chronic inflammation in their liver so called chronic hepatitis in dogs. We are performing this study to evaluate whether these blood tests correlate with the severity of the dog’s liver disease.

    Inclusion Criteria:

    • Dogs weighing greater than 6 kg (13 lbs)
    • Dogs with histologically confirmed chronic hepatitis

    Exclusion Criteria:

    • history of use of corticosteroids, ursodeoxycholate, NSAIDs, omega-3 or vitamin D supplementation within 2 weeks of enrollment or the use of DDAVP within 24 hours
    • degenerative mitral valve disease, renal disease (Creat >2.0 mg/dL), concurrent active infection, neoplasia, IBD, immune mediated hemolytic anema, pnacreatitis or immune mediated polyarthropathy

    Client Benefits:

    The study will cover the costs of the vitamin D, CRP and von Willebrand factors as well as a complete blood count and serum chemistry at the first recheck appointment.

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

     

     

  • Status:  Currently enrolling

    Description

    The goal of this study is to assess the presence and degree of vascular abnormalities which are thought to exist within the eyes of diabetic canines. Diabetes is one of the most common endocrinopathies affecting dogs. In humans, diabetes results in microangiopathies (diabetic iridopathy and retinopathy) which are significant vision threatening sequelae. While noted to occur in diabetic canines, little published information exists regarding its degree and/or severity. This study will perform a diagnostic work up, including a 24 hour blood glucose curve, in addition to, ocular angiography using both sodium fluorescein and indocyanine green, in a total of 8 diabetic canines. Our goal is to document and characterize vasculature changes (vascular leakage, delayed perfusion) which are thought to occur in diabetic dogs and correlate them to disease status and/or duration. Data generated herein, will provide the necessary information for conducting longitudinal studies, correlating the prevalence and severity of these vascular abnormalities to the duration of disease and regulation status. Knowledge regarding the prevalence and severity of these vascular abnormalities could translate into better preventative medicine and/or improved patient outcomes following surgery (i.e. cataract surgery) in our canine patients.

    Inclusion Criteria

    1. New or previously diagnosed canines with diabetes mellitus. A diagnosis of diabetes mellitus is based on a history of polyuria, polydipsia, polyphagia, blood glucose above 250mg/dl, and glucosuria.

    Exclusion Criteria

    1. Diabetic canines exhibiting any signs/symptoms suggestive of concurrent systemic disease(s) will not be considered.  Excluding conditions include diseases that cause insulin resistance such as hyperadrenocorticism and/or those which may be associated with vascular abnormalities (i.e.renal failure, neoplasia, and heart failure)
    • Dogs receiving corticosteroids within the previous 30 days will be excluded.

     Client benefits

    The study will cover the following costs associated with participation in this study: the cost of a complete blood count, serum biochemistry profile, urinalysis and culture. Additionally, costs of conducting a 24 hours blood glucose curve (including hospitalization charges) and a fructosamine level will be covered. For angiographic purposes, canines will be sedated the following day and receive intravenous administration of two commonly employed angiographic dyes. The study will cover the costs associated with conducting ocular angiography.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

  • Status: Currently enrolling

    Description:

    Hyperammonemia has been documented in several disease states in cats, but no studies have systematically evaluated blood ammonia levels in cats with renal azotemia.  The objective of this pilot study will be to document blood ammonia levels in cats that present for evaluation of renal azotemia. We hypothesize that fasting blood ammonia will correlate with the blood urea nitrogen and creatinine in these cats.

    The blood ammonia level will be available for interpretation by the investigator within 2-3 hours of blood collection. If hyperammonemia is documented, we will enact therapy to decrease the blood ammonia level during the hospitalization stay.  We will also be measuring serum B12 (cobalamin) levels and if these are low, we can supplement the cats. Beyond benefit to the enrolled cats, this study will direct the design of a future study to evaluate if the results are repeatable in a larger population

    Inclusion Criteria:

    Cats with the confirmed presence of renal azotemia on labwork (IRIS Stage ≥ 2: creatinine ≥ 1.6 mg/dL) that either have a history of previous kidney disease, or are newly diagnosed.

    Exclusion Criteria:

    Cats with previously diagnosed concurrent disease states known to have increased ammonia levels will be excluded from the study (e.g. congenital portosystemic shunts, previously documented cobalamin deficiency); however, cats will be screened for a cobalamin deficiency in the event the deficiency is undiagnosed.                                    In addition cats on medications known to decrease blood ammonia (antibiotics, lactulose) will be excluded.

    Client Benefits:

    The cost of the blood ammonia and cobalamin levels will be covered by the study.Your pet’s participation will also allow us to gain information which could help in the diagnosis, management, and treatment of other cats with this condition.

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

  • Status:  Currently enrolling

    Description:

    To determine if losartan, a medication used to reduce protein loss through the kidneys, is broken down and processed differently in dogs with kidney disease compared to healthy dogs.

    To compare the ability of losartan to control protein loss through the kidneys in dogs with protein-losing kidney disease (protein-losing nephropathy, or PLN) with benazepril, one of the medications in the class of medications (angiotensin-converting enzyme inhibitors) that is currently standard therapy for this disease.

    We hypothesize that the processing of losartan in dogs with PLN will be altered compared to the patterns previously established in healthy dogs, and that losartan will be equally or more effective than benazepril at treating PLN.

    This study serves to evaluate losartan, a medication commonly used in human medicine, for its role in helping to treat protein-losing nephropathy, a potentially devastating disease in dogs.  If successful, this may open a new option for treatment of dogs with PLN who don’t respond to standard therapies, such as benazepril.  In addition, the pharmacokinetics of losartan (or any angiotensin-receptor blocker) in dogs with PLN has not been previously evaluated.

    Inclusion Criteria:

    Dogs who have been diagnosed with protein-losing nephropathy (as defined by having a urine protein:creatinine ratio >2.0 with no evidence of non-renal causes of proteinuria).

    Client benefits:

    The direct benefit from this study for your dog is that he or she will receive one of two promising therapies for protein-losing kidney disease with close monitoring of his or her response to therapy.  The direct benefit to you is that the costs of either medication (benazepril or losartan) will be covered for the duration of the study (6 months).  You will be responsible for the costs of the preliminary diagnostic tests (including ultrasound) and the costs of the recheck appointments and urine and blood testing at these rechecks.

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

     

  • Status:  Currently enrolling

    Description:

    We hypothesize that the orally administered drug, bexagliflozin, will improve glycemic control in poorly regulated diabetic cats. The primary objective of this study is to determine if mean blood sugar and fructosamine concentrations decrease by ≥10% with administration of bexagliflozin over a two week period. The secondary objective is to determine if bexagliflozin is well tolerated by poorly regulated diabetic cats.

    Inclusion Criteria:

    Cats with unregulated diabetes mellitus based on history of persistent hyperglycemia(>250 mg/dl) and appropriate clinical signs, including polyuria, polydipsia and weight loss

    Exclusion Criteria:

    Cats with documented azotemia, elevated bilirubin, ALT >2.5x the upper limit of normal, diabetic ketoacidosis, urinary tract infection, use of corticosteroids within the past 8 weeks, heart disease requiring medication and uncontrolled hyperthyroidism based on preliminary laboratory testing

    Client benefits:

    The study will cover the costs of blood work and urine tests required for the study, blood pressure measurement, day boarding as well as the cost of the medication.  We will be teaching you how to monitor your cat's blood glucose levels at home with a hand held glucometer that will be loaned from our hospital for the duration of the study.

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

     

     

     

     

     

     

  • Sponsor: Private Foundation

    IACUC Protocol # G2016-134

    Status:  Currently enrolling

    Description:

    Dogs develop inflammatory bowel disease (IBD) spontaneously, which results in persistent or recurring signs such as weight loss, vomiting, and/or diarrhea, and is characterized by inflammatory cell infiltration in the intestine.

    In both humans and dogs, IBD is considered to be an idiopathic, chronic, relapsing immune-mediated inflammatory disorder of the GI tract that involves the interplay between genes, diet, and the microbes in the intestine. The treatment for IBD in both dogs and humans is similar, and relies on diet, immune suppression.

    The goals of this experiment are: 1) to evaluate the gene expression of the white blood cells in the intestine and the blood of dogs with inflammatory bowel disease compared to normal dogs, and 2) to evaluate the in vitro response to activation of the T cells in the blood and intestine of dogs with IBD and normal dogs, and 3) to determine in vitro if extracellular vesicles (EV) derived from canine mesenchymal stem cells (MSC) or the MSC themselves are able to reduce the inflammation seen in dogs with IBD.

    MSC are cells derived from the tissue around the umbilical cord, which are known to have anti-inflammatory and regenerative properties. EV are nanoparticles released from the MSC, which contain many signaling molecules that are also potentially capable of anti-inflammatory properties.

    Inclusion Criteria:

    IBD group:

    Dogs over 1 year of age and weighing > 5 kg undergoing upper gastrointestinal endoscopy for evaluation of a history of chronic gastrointestinal signs of at least 3 weeks duration (vomiting, diarrhea, and/or weight loss) will be considered. These dogs will have no identifiable cause for their clinical signs on routine diagnostic evaluation (complete blood count, serum chemistry, urinalysis, baseline cortisol). Dogs will need to have had a veterinarian-recommended diet trial for at least 1 week with incomplete resolution of signs, as well as be incompletely responsive to an antibiotic trial with metronidazole or tylosin. Eligible dogs will have had a negative fecal floatation and Giardia ELISA or negative zinc sulfate floatation, or be non-responsive to a treatment course with fenbendazole (50 mg/kg daily for 3 days).

    Control dogs for blood and GI tissue acquisition will include otherwise healthy dogs undergoing endoscopy for foreign body retrieval and weighing > 5 kg. Dogs will have no evidence of systemic disease (change in weight, thirst, urination, activity level), and no history of gastrointestinal signs unrelated to recent foreign body ingestion.

    Exclusion Criteria:

    Dogs with cancer detected on physical examination or diagnostics performed will be excluded. Dogs cannot be on topical or oral short acting steroid therapy (prednisone or prednisolone), other oral immunosuppressants (i.e., azathioprine, cyclosporine), or oral non-steroidal anti-inflammatory (i.e., Rimadyl, Deramaxx) medication for at least 1 week prior to biopsy. Antibiotic therapy will not exclude a patient from enrollment.

    Client Benefits:

    Fees associated with histopathology (microscopic evaluation of the intestinal tissue) performed during the study will be covered during your participation in the study. Costs incurred by additional anesthesia time over that needed for diagnostic biopsy collection or foreign body removal will be covered by the study.

    In the event any complications arise during endoscopy, their management will be covered by you.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu