Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis

Korábbi kezelés

• History of use of an investigational drug within 90 days prior to the screening visit.

Más betegség

• Positive results for active HIV, Hepatitis B, or Hepatitis C infections.
• History of recurrent Clostridium difficile infection or FMT in the past 6-months.
• History of other active gastrointestinal conditions such as irritable bowel syndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy, gastrointestinal fistulae or strictures, chronic parasitic infections, diverticulitis etc.
• Known history of bile acid diarrhea
• Compromised immune system (e.g. primary immune disorders or clinical immunosuppression due to a medical condition or medication e.g. taking oral prednisone >20 mg a day or prednisone-equivalent)
• History of active cancer and/or ongoing chemotherapy (superficial non-metastatic cancers and maintenance chemotherapy are permitted).
• History of significant uncontrolled systemic disease that in the opinion of the study investigator could interfere with study participation and/or objectives.

Egyéb

• Unable to take multiple capsules orally.
• Females who are pregnant, breastfeeding, or planning to become pregnant during the study.
• Receipt of systemic non-topical antibiotics within 14 days of treatment day 1.
• Life expectancy of < 1 year.
• In the opinion of investigator, subject for any reason, should be excluded from the study.

• Adult ≥18 years of age
• History of active UC in the past 12 months based on standard clinical, endoscopic, or histologic criteria.
• Remission of UC based on clinical grounds (partial Mayo score of ≤2 with each subscore ≤1), and on stable maintenance therapy.
• Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the study.
• Female subjects of childbearing potential must have a negative urine Qualitative HCG pregnancy test at enrolment and on the Week 1, Day 1 of the Treatment prior to administration of study drug.
• Willing and able to sign an informed consent form and attend all study-related clinic visits, assessments, and follow-up phone calls.
• Subject has an attending physician who will provide the non-FMT care.