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

Entrinsic Bioscience

Status: Terminated

Conditions: Ileostomy - Stoma; Short Bowel Syndrome; Inflammatory Bowel Diseases

Treatments: Other: amino acid mixture beverage; Other: glucose-based sports drink

Study type: Interventional

Funder types: Industry

Identifiers

NCT03451253

2017P000097

Details and patient eligibility

About

This pilot study will examine the benefit of this amino acid based hydration solution in patients with IBD who have undergone a total colectomy and have either ileostomies or jpouches. Findings from this study and possible future studies could have broad implications for patients with malabsorption resulting from many underlying conditions, including IBD.

Full description

This pilot study will examine the benefit of this amino acid based hydration solution in patients with IBD who have undergone a total colectomy and have either ileostomies or jpouches. Findings from this study and possible future studies could have broad implications for patients with malabsorption resulting from many underlying conditions, including IBD.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Colectomy with ileostomy

   a. Ileostomy alone with less than 30 cm of small bowel resected i. A diverting ileostomy is permitted

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

3. Any of the following:

   1. Need for IV fluids >2x/month
   2. Intake of > 1.5 liters of oral fluid daily

4. 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)

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

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

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

Exclusion:

1. Chronic renal insufficiency glomerular filtration rate (GFR) < 40

2. Significant chronic liver disease altering fluid balance

3. Uncontrolled flare of inflammatory disease

   a. (Inflammation can be present but at a stable at least partly controlled level) b. An anticipated change in medication in the next 3 months i. May be included 8 weeks after changing medications if they are stable c. Anticipated gastrointestinal surgery in the subsequent 3 months i. May be included if they are 4 months out from surgery and stable

4. Diabetes

5. Use of Lactulose/Mannitol solution is contraindicated

6. Current Diagnosis of Cancer

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

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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7 participants in 2 patient groups

amino acid mixture beverage

Experimental group

Description:

amino acid based hydration beverage. It will be given 8 oz, twice daily for the first 4 weeks of randomized blinded intervention. It will be given in same dose during 4 week open label intervention.

Treatment:

Other: amino acid mixture beverage

glucose based sports drink

Active Comparator group

Description:

glucose based hydration beverage. It will be given 8oz, twice daily for the first 4 weeks of randomized blinded intervention.

Treatment:

Other: glucose-based sports drink