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Clinical Trials

Ongoing Study Opportunities

The medical world is constantly advancing and developing new treatments for various disease processes. Speak with your gastroenterologist to see what study may be right for you. Please check back frequently for newly enrolling studies.

If you are interested in a clinical trial, contact our office at 440-205-1225 ext 6. Our study coordinator can provide you with the information you need or answer questions you may have.

C. Diff (Clostridioides Difficile)

First episode or first re-occurrence of C. Diff infection

Oral pill, 10-week study, narrow spectrum antibiotic, no placebo, investigational product versus vancomycin

Celiac Disease

Ages 18-70 years old with a previous diagnosis of celiac that have followed a gluten free diet over 12 months, must be willing to participate in gluten challenges

Investigational product that re-educates t-cells to not respond to gluten, intravenous infusion, 52 week study, 3 out 4 chance to get investigational product versus a placebo

Colorectal Cancer Screenings (CRC)

45 years old or older, first-time colonoscopy or at least 9 years since your last colonoscopy.  Participant must not be having GI symptoms that may need to be investigated by physician

Stool Collection Testing

Blood Collection Testing

Blood and Stool Collection Testing

Colorectal Cancer Screenings - Device Trial

Up to 8 weeks study, must be ages 45-75 years old, committed to undergo a screening colonoscopy.  Cannot have diabetes type 1, chronic constipation defines as <3 bowel movements per week, use of narcotics or cannabis

A panoramic imaging ingestible capsule

Crohn's Disease

Must have been diagnosed for at least 3 months, currently experiencing symptoms such as abdominal pain, frequent loose stools, urgency etc., and failed to respond to steroid, immunosuppression, or a biologic therapy

An S1P modulator, oral pill, 52 week treatment with open label after 12 weeks, meaning no placebo after first 12 weeks

Check Back …..another exciting Crohn’s study coming soon!

Crohn’s Disease/Ulcerative Colitis - Device Trial

Must be symptomatic with moderate to severe disease

SNS (Sacral Nerve Stimulator):  implantation of SNS device that delivers impulses to the nerves in the pelvis to treat IBD symptoms

Eosinophilic Esophagitis (EOE)

Already been diagnosed with EOE and having symptoms such as difficulty swallowing at least 2 days per week and have failed standard of care treatment such as PPI, swallowed steroids, or an elimination diet

Anti-KIT IGGI Tyrosine Kinase
A protein that blocks cells that cause inflammation subcutaneous injection, 50 week study, open label after 12 weeks, meaning no placebo after first 12 weeks

Fissures

Check Back Coming Soon! Fissure detected with anal pain for at least 4 weeks, participant cannot have history of constipation, uncontrolled blood pressure, cigarette smoking, marijuana use

A topical gel, 10-week study, 2/3 chance to receive investigational product versus placebo

GERD (Gastroesophageal Reflux Disease)

Must have heartburn and regurgitation.  Cannot be taking PPIs or use of any gastric suppression 2 weeks prior to endoscopy.  Cannabis, opiate, and sleeping pill use allowed only if you have a prescription and been on for 6 months

Oral pill, potassium blocker for maintenance and healing of erosive esophagitis, 32-week study, comparator medication is Lansoprazole.  (no placebo) open label extension study will be available soon

Liver Study - NAFLD (Non-Alcoholic Fatty Liver Disease) or NASH (Non-Alcoholic Steatohepatitis)

Must have a BMI >30 kg, Diabetic Type II, on stable dose of DPP-4/sgl-2 with HgbA1C stable between 6.5-10.5%, must have attempted weight loss once in the last 6 years, possibly willing to undergo Fibroscans, MRIs, and liver biopsy.

Oral pill, investigational product expected to improve metabolism, steatosis, inflammation, fibrosis, and vasculature to liver, part 1:  2 out of 3 chance to receive investigational product for up to 72 weeks, part 2:  open label (no placebo) up to 7 years

Oral pill, investigational product works by increasing mitochondrial inefficiency and expected to prevent progression of NASH, reduction of body and liver weight, reduction of liver histology hallmarks of NASH, 26-week study

Liver Study - Prevention of Overt Hepatic Encephalopathy

Must have a diagnosis of liver cirrhosis with medically controlled ascites not requiring a paracentesis in the last 30 days

Oral pill, 80 week study with 50% chance of receiving investigational product versus placebo

Proctitis

Confirmed or suspected with symptoms such as stool frequency, rectal bleeding, abdominal pain, etc.

Hydrocortisone Acetate Suppository, 9 week treatment with 2/3 chance for getting the hydrocortisone acetate suppository

Ulcerative Colitis

Must have been diagnosed for at least 3 months, currently experiencing symptoms such as abdominal pain, frequent loose stools, urgency, rectal bleeding, etc. And failed on standard of care treatment or biologics

An S1P modulator, oral pill, up to 3.4 years treatment with no placebo

An anti-integrin, oral pill, 52-week treatment with open label after first 12 weeks meaning no placebo after first 12 weeks

A new mechanism of action that inhibits cytokine expression, oral pill, 52 week treatment with open label after 12 weeks, meaning no placebo after first 12 weeks

Upcoming Study Opportunities

Barrett’s Esophagus

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Chronic Constipation

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Chronic Diarrhea

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Gastroparesis

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Hemorrhoids

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Hepatitis

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Irritable Bowel Syndrome - Constipation

Constipation:  Check Back

Irritable Bowel Syndrome - Diarrhea

Diarrhea: Check Back Coming Soon!

Pancreatitis

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Prep

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How to participate in a clinical trial?

  • Speak with your gastroenterologist to see what study may be right for you.
  • If you are interested in a clinical trial contact our office at 440-205-1225 ext 6. A study coordinator can provide you with information that you need or answer questions you may have.