Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis

Recruiting

I'm Interested

Trial ID: NCT01953354

Purpose

The purpose of this study is to evaluate the safety and effectiveness of trichuris suis ova (TSO) in ulcerative colitis (UC). We will look at how TSO affects the body's immune response and if there are related changes in participants' UC.

Official Title

A Prospective, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study of Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis and Its Effects on Mucosal Immune State and Microbiota

Eligibility


Inclusion Criteria:

   1. Subject has provided written informed consent

   2. Diagnosis of UC (newly diagnosed or established patients) as determined by medical
   history, endoscopic and histological confirmation with the proximal disease extent
   limited to the left colon (distal to the splenic flexure), and accessible by flexible
   sigmoidoscopy. Patients with left-sided disease and the presence of a periappendiceal
   red patch (limited cecal inflammation) will be eligible as long as there is no
   intervening evidence of colitis between the cecal base and the upper boundary of
   inflammation in the left colon.

   3. Mayo score >/= 4, as scored at Screen 2

   4. If taking the following medications at Screen 1, subjects must meet the following
   criteria:

      1. Oral Corticosteroids: stable treatment for at least 4 weeks prior to Day 0 with a
      maximum dose equivalent to <\=15 mg/day of prednisone

      2. Immunosuppressants (azathioprine (AZA) or 6-mercaptopurine (6-MP)): treatment for
      at least 12 weeks with a stable dose, not exceeding 2.5 mg/kg/day of AZA or 1.5
      mg/kg/day of 6-MP, during the 4 weeks prior to Day 0

      3. Aminosalicylates: stable oral doses up to 4.8 g/day for at least 4 weeks prior to
      Day 0.

Exclusion Criteria:

   1. Subjects whose UC is anticipated to require surgical, endoscopic, or radiologic
   intervention during study participation

   2. Uncontrolled GI bleeding

   3. Subjects who have disease limited to the rectum (maximum disease extent of less than
   15 cm)

   4. Women who are pregnant, breast-feeding, or planning to become pregnant during the
   study. All women of childbearing potential must have a negative serum pregnancy test
   at Screen 2 prior to randomization of treatment.

   5. Women of childbearing potential not using adequate birth control measures (e.g., total
   abstinence, oral contraceptives, intrauterine device, barrier method with spermicide,
   surgical sterilization, Depo-Provera, or hormonal implants).

   6. Current or recent serious systemic disorder including clinically significant
   impairment in cardiac, pulmonary, liver, renal, endocrine, hematologic, or neurologic
   function, based on investigator discretion

   7. Subjects currently receiving the following concomitant medications:

      1. Prednisone or its equivalent at unstable doses or at doses exceeding 15 mg/day
      within 4 weeks prior to Day 0

      2. Local steroids such as budesonide, Colifoam, or Predsol enemas within 2 weeks
      prior to Screen 2

      3. Topical therapies, either mesalamine or steroids, taken within 2 weeks of Screen
      2

      4. Non-steroidal anti-inflammatory drugs (NSAIDs), Cyclooxygenase (COX)-2
      inhibitors, or aspirin >100 mg/day within 2 weeks prior to Screen 2

      5. Tumor necrosis factor (TNF)-alpha inhibitors including but not limited to
      infliximab (Remicade) or adalimumab (Humira) within 12 weeks of Day 0

      6. Any biological agent within 12 weeks of Day 0

      7. Metronidazole within 4 weeks of Day 0

      8. Receipt of any investigational agent within the 12 weeks prior to Day 0

      9. Antibacterial or oral antifungal agents within 4 weeks of Screen 2

   10. Interferon (IFN) therapy

   11. Anticoagulants

   12. Methotrexate

   8. Blood transfusion within the 12 weeks prior to Day 0

   9. Presence of any of the following abnormal laboratory parameters at Screen 1:

      1. Hemoglobin < 10.0 g/dL

      2. White Blood Count (WBC) < 4,000 or > 20,000/L (equivalent to WBC < 4 or > 20
      x109/L)

      3. Platelets < 100,000 or > 800,000/L (equivalent to platelets < 100 or > 800
      x109/L)

      4. Total bilirubin > 1.5 × Upper limit of normal (ULN)

      5. Alanine transaminase (ALT) > 2 × ULN

      6. Aspartate transaminase (AST) > 2 × ULN

      7. Alkaline phosphatase (ALK) > 1.5 × ULN

      8. Gamma-glutamyl transferase (GGT) > 1.5 × ULN

      9. Creatinine > 1.5 × ULN

10. History of drug or alcohol abuse within one year prior to Day 0

11. Inability to understand the nature and requirements of the study, or to comply with
   the study procedures or planned schedule of study visits

12. Evidence of infection with human immunodeficiency virus (HIV), hepatitis B, or
   hepatitis C

13. Active infection with C. difficile, bacterial enteric pathogens, or pathogenic
   ova/parasites

14. History of malignancy within the last 5 years, except for resected basal or squamous
   cell carcinoma, treated cervical dysplasia, or treated in situ cervical cancer Grade I

15. History of colonic dysplasia

16. Any social or medical condition that, in the opinion of the investigator, would
   preclude provision of informed consent, make participation in the study unsafe,
   complicate interpretation of study outcome data, or otherwise interfere with achieving
   the study objectives.

Intervention(s):

biological: Trichuris suis ova (TSO)

biological: Placebo

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Narinder Bolaria
650-736-7081