Current Research Studies
Crohn’s (multiple options – with placebo chance 20-50%)
- 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
- 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%)
- 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.
- 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)
- 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.
- 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)
- 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
- 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
- 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.
- 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
- 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