About The Louisiana Research Center, LLC
The Louisiana Research Center, LLC is a clinical research center owned and operated by gastroenterologists who are also partners in the group practice of GastroIntestinal Specialists, A.M.C. The Center is able to serve you with two locations. The practice has participated in investigational studies since 1992, and the successful completion of these studies led to the formation of Louisiana Research Center. There are three full-time research coordinators on staff.
The consistent ability to recruit and enroll patients and complete studies in a timely and professional manner has resulted in a high level of satisfaction for both clinical research organizations and sponsoring pharmaceutical companies.
Since 1992 we have participated in and completed studies involving peptic ulcer disease (with Helicobacter pylori), erosive esophagitis, gastroesophageal reflux disease, non-erosive esophagitis, anal-rectal disease, chronic constipation, diarrhea, irritable bowel syndrome, inflammatory bowel disease, and hepatitis C.
We have also performed studies in healthy volunteers to study the possible effects of medications on the gastrointestinal tract. Louisiana Research Center is actively pursuing participation in additional gastrointestinal studies.
- Associated with the largest group of board certified gastroenterologists in the Ark-La-Tex.
- Utilizes a centralized institutional review board (IRB).
- Adheres to Good Clinical Practice Guidelines.
- Has access to a large population base with a diverse array of pathology.
- Utilizes the Shreveport Endoscopy Center for studies requiring endoscopic procedures.
- Has been highly successful in patient recruitment.
- Has an excellent record of timely completion of studies with accurate and complete source documents.
Crohn’s (Multiple Options – with placebo chance 20-50%)
*Documented diagnosis of CD with a minimum disease duration of 3 months
*Daily stool frequency ≥ 4
*Endoscopic evidence of active disease as measured by SES-CD Total score ≥ 6
*Wash out 6-8 weeks
- a) Symptomatic strictures, OR
- b) Severe (impassable) rectal/anal stenosis, OR
- c) Fistulae, OR
- d) Short bowel syndrome, OR
- e) Have any current abscesses or infections
*History of malignancy within the last 5 years except non-melanoma skin cancer
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 (multi 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
IBS-C – Linaclotide
- Patient meets Rome III criteria for IBS: reports abdominal pain or discomfort at least 3 days/month during 3 months before diagnosis with onset at least 6 months before diagnosis
- Patient reports <3 BM per week for at least 12 weeks prior to Screening or before starting chronic constipation treatment
- Prior history of IBD
- Patient has a history of diverticulitis or any chronic condition ( chronic pancreatitis, ovarian cysts, endometriosis) with ongoing symptoms that can be associated with abdominal pain or discomfort
- Patient has taken linaclotide or plecanatide during 30 days before Screening
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
Cohorts A & C
- Looking for patients newly diagnosed with Colorectal cancer via colonoscopy report and pathology report
- Need to be enrolled before surgery