Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Colitis, Ulcerative

In brief

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.

Key facts

Study ID

NCT01953354

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

16

Starts

2013-11-01

Expected to finish

2015-11-01

Last updated by the study team

2017-03-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has provided written informed consent
• 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.
• Mayo score >/= 4, as scored at Screen 2
• If taking the following medications at Screen 1, subjects must meet the following criteria:
• Oral Corticosteroids: stable treatment for at least 4 weeks prior to Day 0 with a maximum dose equivalent to <\\=15 mg/day of prednisone
• 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
• Aminosalicylates: stable oral doses up to 4.8 g/day for at least 4 weeks prior to Day 0.

You may not qualify if…

• Subjects whose UC is anticipated to require surgical, endoscopic, or radiologic intervention during study participation
• Uncontrolled GI bleeding
• Subjects who have disease limited to the rectum (maximum disease extent of less than 15 cm)
• 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.
• 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).
• Current or recent serious systemic disorder including clinically significant impairment in cardiac, pulmonary, liver, renal, endocrine, hematologic, or neurologic function, based on investigator discretion
• Subjects currently receiving the following concomitant medications:
• Prednisone or its equivalent at unstable doses or at doses exceeding 15 mg/day within 4 weeks prior to Day 0
• Local steroids such as budesonide, Colifoam, or Predsol enemas within 2 weeks prior to Screen 2
• Topical therapies, either mesalamine or steroids, taken within 2 weeks of Screen 2
• Non-steroidal anti-inflammatory drugs (NSAIDs), Cyclooxygenase (COX)-2 inhibitors, or aspirin >100 mg/day within 2 weeks prior to Screen 2
• Tumor necrosis factor (TNF)-alpha inhibitors including but not limited to infliximab (Remicade) or adalimumab (Humira) within 12 weeks of Day 0
• Any biological agent within 12 weeks of Day 0
• Metronidazole within 4 weeks of Day 0
• Receipt of any investigational agent within the 12 weeks prior to Day 0
• Antibacterial or oral antifungal agents within 4 weeks of Screen 2
• Interferon (IFN) therapy
• Anticoagulants
• Methotrexate
• Blood transfusion within the 12 weeks prior to Day 0
• Presence of any of the following abnormal laboratory parameters at Screen 1:
• Hemoglobin < 10.0 g/dL
• White Blood Count (WBC) < 4,000 or > 20,000/L (equivalent to WBC < 4 or > 20 x109/L)
• Platelets < 100,000 or > 800,000/L (equivalent to platelets < 100 or > 800 x109/L)
• Total bilirubin > 1.5 × Upper limit of normal (ULN)

Where it is running

• Stanford University School of Medicine — Palo Alto, California, United States
• Yale University — New Haven, Connecticut, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• University of Iowa Hospital — Iowa City, Iowa, United States
• University of Maryland — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Weill Cornell Medical College — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Drexel University — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• Virginia Mason Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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