Current Research Studies

Crohn’s (multiple options – with placebo chance 20-50%)

Inclusion Criteria

  • Documented diagnosis of CD with a minimum disease duration of 3 months
  • Daily stool frequency
  • Endoscopic evidence of active disease as measured by SES-CD Total score
  • Wash out 6-8 weeks

Exclusion Criteria

  • Symptomatic strictures, OR
  • Severe (impassable) rectal/anal stenosis, OR
  • Fistulae, OR
  • Short bowel syndrome, OR
  • Have any current abscesses or infections
  • History of malignancy within the last 5 years, except non-melanoma skin cancer
Crohn’s Biomarker Study
  • 18 and over
  • Diagnosis of CD
  • No UC or indeterminate colitis
  • No investigational agents within 30 days of screening that is part of a double-blinded study
Ulcerative Colitis (multiple options – with placebo chance 20-50%)

Inclusion Criteria:

  • Must have been diagnosed for at least 3 months.
  • Tried 5-ASA, Steroids, immunomodulators and/or biologics and either failed, lost response or been intolerant.
  • Must be willing to use highly effective birth control.
  • Disease at least 15 to 20 cm from the anal verge, no Proctitis only.
  • Must be symptomatic with rectal bleeding and increased diarrhea.

Exclusion Criteria

  • Indeterminate Colitis or Crohn’s must be definitively UC
  • No colon resections/surgeries for UC
  • No chronic NSAID use
  • No C. diff. currently or recent Live vaccines
  • No current Anemia, must be Hgb >9g/dL
  • Wash out 6-8 weeks
NASH (multiple options)

Inclusion Criteria:

  • 18-75 years of age
  • F2-F4 fibrosis by fibroscan and NAFLD Score
  • No change in medication for diabetes, hypertension or hyperlipidemia; or change in Vitamin E for 6 months prior to diagnostic liver biopsy/screening.

Exclusion Criteria

  • History of decompensation
  • AST/ALT ≥ 5 x Upper Limit of Normal
  • Platelets ≤100,000/ mm3
  • Prior or planned bariatric surgery
  • History of cancer, cardiovascular or cerebrovascular event within last 5 years
Recurrent C. diff. (RBX2660: microbiota suspension (enema)

Inclusion Criteria:

  • Recurrent C-Diff – 1 -2 recurrence; can be on antibiotics at time of referral
  • Positive stool test for diff within 30 days prior to enrollment
  • Currently taking or was just prescribed antibiotics to control CDI-related diarrhea at the time of enrollment (CDI diarrhea must be controlled <3 unformed/loose stools/day).
  • Willing and able to have enemas

Exclusion Criteria

  • Currently has continued CDI diarrhea despite being on a course of CDI antibiotic treatment.
  • History of IBD, IBS, ostomy, chronic diarrhea, celiac disease or any disease requiring antibiotic therapy.
  • Previous fecal transplant, RBX2660 treatment, receipt of CDI vaccine
  • ANC <1000 cells/µL
CRC Screening Study

Cohort B:

  • Patients 50-84 who have had not had a colonoscopy in the past 9 years
  • Cannot have a hx of copo (unless hyperplastic only) or coca
  • Cannot have IBD or previous hx of bowel resection
  • Cannot have 2+ immediate family members diagnosed with CRC

Cohort A & C:

  • Looking for patients newly diagnosed with Colorectal cancer via colonoscopy report and pathology report.
  • Need to be enrolled before surgery.
CRC Screening
  • 40 years or older
  • DX of CRC at any stage confirmed by tissue biopsy or colorectal lesion at least 1 cm in size
  • No previous cancer diagnosis
PBC
  • 18-75 years old
  • Document Liver biopsy (no cirrhosis)
  • History of ALP above ULN for at least 6 months
  • No prior TX with OCA

Please call (318) 525-3233 for more information. Updated 3/6/19