Short Bowel Syndrome
Conditions
Brief summary
We plan to examine the gastrointestinal (GI) physiologic profile of Exenatide, a glucagon-like peptide (GLP-1) analog as a possible intestino-trophic growth factor capable of inducing small bowel adaptation and regeneration in patients with short bowel syndrome (SBS), with the potential to decrease parenteral nutrition dependence.
Interventions
DRUGExenatide
Qualifying participants will be assigned to 2 different treatment arms consisting of placebo or exenatide 5 mcg administered subcutaneously twice: the first dose during fasting and the second four hours later. Subsequently, participants will switch over to the alternate treatment arm. In both arms participants will undergo a series of measurements including 24 hour GI transit, permeability measurements by using mannitol and lactulose, and 24 hour urine and stool collections.
DRUGPlacebo
Qualifying participants will be assigned to 2 different treatment arms consisting of placebo or exenatide 5 mcg administered subcutaneously twice: the first dose during fasting and the second four hours later. Subsequently, participants will switch over to the alternate treatment arm. In both arms participants will undergo a series of measurements including 24 hour GI transit, permeability measurements by using mannitol and lactulose, and 24 hour urine and stool collections.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Patients with short bowel syndrome, between the ages of 18-85 who are dependent on parenteral nutrition for at least a year and are being closely followed by the Mayo Clinic Home Parenteral Nutrition Program (HPN) with at least one multisystem evaluation a year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24hr Gastrointestinal and Colonic Transit before and after Exenatide vs placebo | In both arms participants will undergo GI transit measurements on 2 seperate occasions for a total of 24 hours, with a wash out period of 48 hours in between transit studies. | To measure gastric, small intestinal and colonic (if applicable) transit in patients with short bowel syndrome (SBS) before and after the administration of Exenatide compared to placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24hr Intestinal Permeability before and after administration of Exenatide vs placebo | In both arms participants will undergo intestinal permeability measurements on 2 seperate occasions for 24 hours,with a wash out period of 48 hours in between permeability studies. . | To measure intestinal permeability to mannitol and lactulose in patients with short bowel syndrome before and after administration of Exenatide compared to placebo |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in 24hr Stool Weight before and after administration of Exenatide vs placebo | In both arms participants will collect stool weight for 24 hours in 2 seperate occasions with a wash out period of 48 hours in between collections. | To measure stool weight in patients with short bowel syndrome before and after administration of Exenatide compared to placebo. |
| Change in 24hr Urine Volume before and after administration of Exenatide vs placebo | In both arms participants will collect urine volume for 24 hours in 2 seperate occasions with a wash out period of 48 hours in between collections. | To measure urine volume in patients with short bowel syndrome before and after administration of Exenatide compared to placebo. |
Outcome results
None listed