Lanreotide in the Treatment of Small Bowel Motility Disorders

Exclusion Criteria

• •1. Age \<18 or age \>70
• •2. Pregnancy as assessed by urine pregnancy test.
• •1. History of gastric bezoar
• •2. History of Disorders of swallowing
• •3. Known or suspected small bowel diverticula, diverticulitis, strictures, fistulas, Crohn's disease, or any other relevant medical comorbidity (e.g. chronic alcohol abuse)
• •4. Prior intestinal surgery, including Ileocecal(IC) valve resection or gastrointestinal surgeries that create a blind loop (e.g. Bilroth II or Roux-en-Y)
• •5. History of Severe dysphagia to food or pills
• •6. A participant who uses an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump
• •7. Inability to be off intestinal transit altering medication for at least one week (e.g. opiates, laxatives, etc.)
• •8. Any person unable or unwilling to undergo abdominal surgery.
• •9. BMI \> 40.
• •1. Current use or recent (within last 7 days) use of acid suppressive therapy, prokinetic agents, laxatives, and opiates, or other agents known to affect gastrointestinal motility.
• •2. Disorders associated with presumed small intestinal motility disorders including: scleroderma, intestinal pseudo-obstruction, and autonomic visceral neuropathy (e.g. longstanding diabetes of more than 20 years and/or poorly controlled diabetes (glucose \> 250, glycosylated hemoglobin (HbA1c) \> 8.5%)
• •3. Current use of cyclosporine (Gengraf, Neoral, or Sandimmune), a medicine called bromocriptine (Parlodel, Cycloset), or medicines that lower heart rate, such as beta blockers.
• •4. Cardiac arrhythmia based on health history (palpitations, feeling a pause between heartbeats, lightheadedness, passing out, shortness of breath, or chest pain).
• •Bradycardia and Tachycardia are monitored during every visit to the clinic, using pulse rate.
• •ECG will be performed during screening visit and during 8th week of the study. The following are accessed with ECG.
• •* Bradycardia \<60 beats/min.
• •* Tachycardia \>100 beats/min.
• •* Atrial Fibrillation - Rapid irregular atrial signal with no real P-waves and irregular ventricular rate.
• •* Ventricular Fibrillation - Irregular ventricular waveforms.
• •* Sinus Arrhythmia - Normal beats, but triggered at an irregular interval from 60 to 100 beats per minute, causing varying R-R interval.
• •* Missed beats.
• •5. Chronic kidney disease (moderate and severe renal impairment as calculated by creatinine clearance of \<50 mL/min)
• •6. Hepatic Impairment - Subjects with Child-Pugh Class B and Class C.
• •7. Significant electrolyte abnormalities: Anything outside of the normal range by +/- 20 % will be considered as abnormal.
• •8. Cholelithiasis (Total bilirubin \>2x of normal)
• •9. Pancreatitis
• •10. Hepatitis (Aspartate transaminase (AST), Alanine transaminase (ALT) or Alkaline phosphatase (Alk Ph), greater than upper limit of normal(ULN), Serum albumin \<3.0 g/dL unless prothrombin time is within the normal range)
• •11. Present cholecystitis
• •12. Uncontrolled congestive heart failure
• •13. Known hypersensitivity to the study drug