Short gut syndrome with intestinal failure patients may have decreased production of disaccharidases, like sucrase, an enzyme responsible for digesting sugar in foods. This can happen due to loss of bowel length from surgery or from loss of cellular function in the intestines due to use of parenteral nutrition intravenously. Therefore, patients with these conditions may not be able to digest sucrose (sugar) fully. Patients might experience abdominal distension/pain, vomiting and diarrhea when sugar is taken in orally or through the g-tube, which can limit patients' ability to increase oral or g-tube feeds in short gut syndrome patients with intestinal failure. In patients with short gut syndrome and intestinal failure, the administration of exogenous sucrase (enzyme) may improve sucrose (sugar) digestion and thus the ability to tolerate more oral or g-tube feeds.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
3
1 mL (8,500 I.U.) (one full measuring scoop or 28 drops) per meal or snack for patients up to 15 kg in body weight. 2 mL (17,000 I.U.) for patients over 15kg in body weight. Dosage is 1 or 2 mL (8,500 to 17,000 I.U.) taken orally or by g-tube with each meal or snack diluted in water, milk, or infant formula.
1 mL of placebo per meal or snack for patients up to 15 kg in body weight. 2 mL of placebo per meal of snack for patients above 15kg in body weight. Dosage is 1 or 2 mL of placebo taken orally or by g-tube with each meal or snack diluted in water, milk, or infant formula.
Jackson Memorial Hospital
Miami, Florida, United States
University of Miami
Miami, Florida, United States
Change in Carbohydrate Malabsorption
Degree of carbohydrate malabsorption will be assessed by decrease in number of stools per day.
Time frame: baseline, 9 weeks
Change in Carbohydrate Malabsorption as Measured by Patient Symptom Survey
Degree of carbohydrate malabsorption will be assessed by change in patient symptomatology by change in score on patient symptom survey. The survey has range from 0-52 with higher score being worse symptoms and lower being better.
Time frame: baseline, 9 weeks
Change in Carbohydrate Malabsorption as Measured by Growth Velocity
Carbohydrate malabsorption will be measured by increase in growth velocity in kg/week
Time frame: baseline, 9 weeks
Change in Carbohydrate Malabsorption as Measured by Enteral Nutrition Tolerance
Carbohydrate malabsorption will be measured by ability to advance enteral nutrition in ml/day
Time frame: baseline, 9 weeks
Change in Digestion
Change in digestion will be measured by change in abdominal distension/girth measured in cm
Time frame: baseline, 9 weeks
Change in Digestion as Measured by Amount of Emesis
Change in digestion will be assessed by number of emesis per day
Time frame: baseline, 9 weeks
Change in Digestion as Measured by Stool Consistency
Change in digestion will be assessed as a change in stool consistency from liquid (7) to solid(1) using Bristol stool chart
Time frame: baseline, 9 weeks
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