Effects of an Amino Acid Mixture on Gastrointestinal Function, Inflammation and Fluid Balance: A Pilot Study in Patients With Inflammatory Bowel Disease

Inclusion Criteria:

- Colectomy with ileostomy:

- Ileostomy alone with less than 30 cm of small bowel resected

- A diverting ileostomy is permitted

- Stable disease activity with no or mild inflammation felt not to significantly impact
gastrointestinal (GI) output.

- Any of the following:

- Need for IV fluids >2x/month

- Intake of > 1.5 liters of oral fluid daily

- GI output of > 1.3 liters in a 24-hour period for three days each week during a 14 day
screening period (does not need to be consecutive days)

- Stable doses of anti-diarrheal agents, octreotide or Gattex

- Stable doses of anti-inflammatory agents and/or antibiotics

- Willing to comply with study visits and assessments, including product intake

Exclusion Criteria:

- Chronic renal insufficiency glomerular filtration rate (GFR) < 40

- Significant chronic liver disease altering fluid balance

- Uncontrolled flare of inflammatory disease

- Inflammation can be present but at a stable at least partly controlled level)

- An anticipated change in medication in the next 3 months

- May be included 8 weeks after changing medications if they are stable

- Anticipated gastrointestinal surgery in the subsequent 3 months

- May be included if they are 4 months out from surgery and stable

- Diabetes

- Use of Lactulose/Mannitol solution is contraindicated

- Current Diagnosis of Cancer

- May be included if they are 4 or more months out from cancer therapy (i.e.
chemotherapy, etc.)

- Aversion to the taste of enterade® or inability to take the product as instructed