Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Trichuris suis ova (TSO); Placebo
Intervention description: Six doses of TSO orally over a ten-week period (e.g., every 2 weeks x 10 weeks for a total of 6 total doses); Six doses of TSO placebo orally over a ten-week period (e.g., every 2 weeks x 10 weeks for a total of 6 total doses)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Ulcerative colitis (UC); Inflammatory Bowel Disease (IBD); Trichuris suis ova (TSO)

Summary:

      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.
    

Eligibility criteria:

        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.