A Trial for Prevention of Loss of the Effect of Biological Drugs in Patients With Inflammatory Bowel Disease

This is an interventional device feasibility trial for Inflammatory Bowel Diseases Read More

Inclusion Criteria:

1. Diagnosis of CD or UC according to validated criteria, with a Crohn's Disease Activity Score (CDAI) of 200-450 at inclusion.
2. Patients on a stable dose within the last 6 weeks of any type of anti TNF agent or any other biological agent
3. 5-ASA (mesalamine), and immunomodulatory, or immunosuppressive agent, and symptomatic relief (anti-diarrheals) for patients are allowed in a stable dose (6 weeks).
4. Non-smoking (by declaration) for a period of at least 6 months.
5. Females of childbearing potential must be non-pregnant (as determined by a serum pregnancy test at screening and again, prior to each dosing session) and agree to use adequate contraceptive means throughout the study.
6. No known history of significant neurological, renal, cardiovascular, respiratory (asthma), endocrinological, gastrointestinal, primary hematopoietic disease, neoplasm, or any other clinically significant medical disorder other than Crohn's disease and its complications, which in the investigator's judgment contraindicate administration of the study medications.
7. No history of drug or alcohol abuse.
8. Screening tests must meet the following criteria: HGB ≥8.5 g/dL, platelets ≥ 100,000/ mm³, WBC: 3500-12,000/mm³, serum albumin above 2.5 g/dL, amylase, lipase and total bilirubin within normal limits. ALT, AST, alkaline phosphatase up to 1.5 times normal limits.
9. No clinically significant abnormalities in screening physical exam.
10. Negative HIV, Hepatitis B and Hepatitis C serology tests within 2 years.
11. Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
12. Patients must satisfy a medical examiner about their fitness to participate in the study.
13. Patients must provide written informed consent to participate in the study.

Exclusion Criteria:

1. Patients with evidence of other serious infectious, autoimmune, hepatic, nephritic or systemic disease or compromised organ function.
2. Patients with a present colostomy, ileostomy or subtotal colectomy with ileorectal anastomosis.
3. Symptomatic stenosis or ileal strictures, x-ray evidence of fibrosed bowel.
4. Patients presenting with, or with a history of persistent intestinal obstruction, bowel perforation, uncontrolled GI bleed or abdominal abscess or infection, toxic megacolon.
5. Patients with fistulating CD.
6. Short bowel syndrome.
7. Patients with a history of GI tract malignancy or IBD-associated malignant changes in the intestines.
8. Patients with any clinically significant abnormality upon physical examination or in the clinical laboratory test values.
9. A change in the dose of the immunomodulatory or immunosuppressive drug within 6 weeks.
10. Over-the-counter drugs, including herbal medications, and prescription drugs (other than those listed above) are not allowed for 7 days prior to first study dosing and throughout the duration of the study
11. Receipt of packed RBC's within 3 months prior to the first study dosing and throughout the study.
12. Participation in another clinical trial within 30 days prior to first drug administration.
13. Patients with an inability to communicate well with the PI and staff (i.e., language problem, poor mental development or impaired cerebral function).
14. Patients with any acute medical situation (e.g. acute infection) within 48 hours of first dosing session, which is considered of significance by the Principal Investigator.
15. Patients who will be unavailable for the duration of the trial, are likely to be noncompliant with the protocol, or who are felt to be unsuitable by the PI for any other reason.