Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis

Korábbi kezelés

• Concurrent C. difficile or other infections
• Prior history of FMT

Más betegség

• Biopsy proven Crohn's disease
• UC patients with severe disease (defined as a total mayo score \>10)
• Clinical complications requiring emergent management (e.g. stricture, bowel obstruction, perforation and/or abscess)
• Treatment for malignancy within past 5 years
• Active or latent tuberculosis
• History of anaphylactic reactions to food allergens or allergy to psyllium husk
• Subject having any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the subject participating in the study, would make it unlikely for the subject to complete the study, or would confound the study.

Laborértékek

• Clinically meaningful laboratory abnormalities
  • Hb: \< 8
  • ALT: greater than 3x the ULN (upper limit of normal)

Egyéb

• Primary sclerosing cholangitis

• Male or Female ≥ 18 years of age.
• Documentation of prior history of mild to moderate UC.
• Endoscopy confirmed active UC ≥ 15 centimeters at week 0 screening colonoscopy.
  • As defined by a total Mayo scoring of 4-10 with an endoscopic sub-score ≥ 1.
• Patients must have a descending intact colon.
• Patients taking steroid or biologic therapy must be on a stable dose for 4 weeks prior to screening and maintained throughout the trial.
• Eligible patients willing to undergo screening testing prior to FMT to document baseline status:
  • Urine Testing
  • Blood Testing
  • Stool Testing
• Patients must discontinue anti-rCDI antibiotics (e.g. vancomycin, fidaxomicin) 48 hours prior to FMT delivery procedure.