Lanreotide in the Treatment of Small Bowel Motility Disorders
Condition: Gastrointestinal Motility Disorder; Intestinal Disease
MeSH terms: Intestinal Diseases
Intervention: Lanreotide
Intervention description: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart
Intervention MeSH terms: Lanreotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Small bowel motility disorder; Slow intestinal motility; Small bowel bacterial overgrowth

Summary:

      This is a human research study looking at the effectiveness of Lanreotide (study medication)
      in treating small bowel motility disorders. It is similar to a natural hormone somatostatin
      that is produced in the body in the stomach, duodenum, pancreas and brain. Somatostatin is a
      growth hormone-inhibiting hormone. Lanreotide is a man made hormone and is a long acting
      medication that is given once a month. It is marketed with a trade name "Somatuline Depot".
      It is given deep subcutaneously (deep within the layers of the skin) in the superior external
      quadrant of the buttock. Injection site will be alternated on subsequent injections.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Consecutive patients with evidence of small bowel motility disorders, referred to (or)
             are patients of the Gastroenterology and Motility Center at Northwell Health System.

          2. Aged between 18 and 70 years.

          3. Subjects should be capable of understanding the study and be able to give informed
             consent.

          4. Patient having small bowel motility disorder as evidenced by delayed small bowel
             transit by wireless motility capsule (WMC) testing to > 6 hours.

          5. To participate in the study, patients will have to stop taking Octreotide (because it
             has the same mechanism of action as the study medication) if they are currently taking
             it; it should be stopped for at least 4 weeks before taking the first dose of this
             study medication.

        General Exclusion Criteria

          1. Age <18 or age >70

          2. Pregnancy as assessed by urine pregnancy test.

        Exclusion Criteria for performing wireless motility capsule testing

          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.

        Exclusion Criteria due to Lanreotide

          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