ACTIVE RESEARCH STUDIES AS OF 5/12/2020

Please help support our research studies listed below. You can EPIC message or email Cecile Guttermuth and copy Salam Zakko with the name of any interested patient. All procedures, study medication, and testing are free and the patients are paid for their time and effort between $150 – $2000 based on the study.

PLEASE

  • Think of these studies on a regular basis as you are seeing every patient every minute.
  • Remember that it is for the benefit of the human race and many times for the benefit of the patient.
  • Know that a suitable patient does not have to have failed conventional therapy.
  • Note that the patient may be willing to volunteer if presented with the opportunity.

If you are interested in even more information or to see a slide presentation, you can go to the “Public Share” on the CTGI desktop and open the “Research Info” folder which has subfolders. The studies are listed below, along with a link to the actual study:

EROSIVE ESOPHAGITIS (EE)

An EGD will be done and if EE was found the patient will be randomized to either vonoprazan (a potassium-competitive acid blocker) or Lansoprazole (no placebo). An EGD will be repeated to confirm healing and then the patient can stay on it for several months for maintenance of healing. Patients must be > 18 years of age.

HELICOBACTER PYLORI INFECTION (HP)

For patients with H pylori but who have never been treated. If confirmed positive, which is done as part of the study, the patient will get an EGD to rule out other issues. If the patient qualifies, the patient will be randomized to either vonoprazan (a potassium-competitive acid blocker) with Amoxacillin, Vonoprazan with triple therapy or Lansoprazole with triple therapy (no placebo). The patient must be > 18 years old and found to have H pylori that has never been treated.

EOSINOPHILIC ESOPHAGITIS (ON HOLD BECAUSE OF COVID)

Once a week SQ dosing of human monoclonal Ab. Patients 12 years of age or older, with documented EOE by Bx who are still symptomatic in spite of being on at least 6 weeks of bid PPI or qd Dexilant.

GASTROPARESIS (ON HOLD BECAUSE OF COVID)

Twice a day tablet of a peripherally acting Dopamine antagonist with presumably no CNS effects. Patients 18 -85 of age and BMI 19 – 40 with idiopathic or diabetic gastroparesis and nausea, who are not on IV, NG, or PEG alimentation and have not had any gastric surgery.

GERD (non-responsive)

Once a day oral bile acid binding resin in a novel delivery method to supplement once a day PPI therapy that the patient should already be on. Patients should be at least 18 years of age or older, have had a single standard dose of the same PPI for at least the past 6 weeks, and have not had any gastrointestinal surgery. The patient will have a free state of the art Bravo Test.

ULCERATIVE COLITIS (Moderate to Severe) (ON HOLD BECAUSE OF COVID)

Treatment with novel oral biologics (Jak1, Tyk2 agents). Age 18-75 year, diagnosed with UC for at least 3 months, with inadequate, loss of response, or intolerance to any treatment other than 5ASA, who have not had any bowel surgery.

CROHN’S DISEASE (Moderate to Severe) (ON HOLD BECAUSE OF COVID)

Treatment with novel oral biologics (Jak1, S1P1, or S1P5 agents). Age 18-75 year, diagnosed with Crohn’s for at least 3 months, with inadequate, loss of response, or intolerance to any treatment other than 5ASA, who do not have ileostomy, colostomy, or >100 cm of small bowel resection.

COLOGUARD NEW DNA STOOL & BLOOD VALIDATION STUDY (ON HOLD BECAUSE OF COVID)

We need blood and stool samples from patients 40 years of age or older who are scheduled to have a colonoscopy for any reason. The patient has to visit us 1-2 weeks before the procedure at our Bristol Center to give us the samples. After giving us the samples, the patient can have the colonoscopy (not covered by the research) with whoever they are scheduled to have it with. All we need is the colonoscopy and pathology reports which we can get from EPIC. The patient will be paid $150 for their effort.

COLOGUARD TEST FOR PATIENTS WITH KNOWN COLONIC TUMORS

Stool and blood samples needed from patients 40 years of age or older who are known to have a colonic tumor >1cm in size which is scheduled to be removed surgically or endoscopically. The patient has to visit us at our Bristol Center to give us the samples >1 week before the scheduled resection. After giving us the samples, the patient can have the resection and all we need is the excision and path reports. The patient will be paid $150 for their effort.