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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of an Amino Acid Mixture Versus a Sugar Based Sports Drink on Gastrointestinal Function, Inflammation and Fluid Balance: A Pilot Study in Patients With Inflammatory Bowel Disease

Conditions
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Inflammatory Bowel Diseases, Short Bowel Syndrome, Ileostomy - Stoma

Intervention / Treatment
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* Other: amino acid mixture beverage
* Other: glucose-based sports drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Colectomy with ileostomy a. Ileostomy alone with less than 30 cm of small bowel resected i. 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: Chronic renal insufficiency glomerular filtration rate (GFR) < 40 Significant chronic liver disease altering fluid balance 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 Diabetes Use of Lactulose/Mannitol solution is contraindicated Current Diagnosis of Cancer a. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 4 week randomized into 2 arms, followed by 4 weeks of open label non-randomized follow-up.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: amino acid mixture beverage<br>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. | Other: amino acid mixture beverage<br>* commercially available amino acid mixture. Contains 5 amino acids, electrolytes and natural flavoring.<br>* Other names: enterade;|
| Active Comparator: glucose based sports drink<br>glucose based hydration beverage. It will be given 8oz, twice daily for the first 4 weeks of randomized blinded intervention. | Other: glucose-based sports drink<br>* Commercially available glucose-based sports drink, contains electrolytes, sugar and artificial flavoring.<br>* Other names: Gatorade;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI output | Change in GI output over a 24 hour period as the average of the 3 days every week for two different periods of 4 weeks | total 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid Balance | Fluid balance - intake vs output | 8 weeks | 
| Tolerability of Drink | Taste perception Survey | 8 weeks | 
| Quality of Life Index | Inflammatory Bowel Disease Questionnaire (IBDQ) | 8 weeks | 
| Quality of Life Index | SF-36 Questionnaire | 8 weeks | 
| Changes in Blood | mm Hg | 8 weeks | 
| Changes in heart rate | Beats per minute | 8 weeks | 
| Changes in Lactulose-Mannitol Test | The standard test for leaky gut syndrome | 8 weeks | 
| Immune Response based on Cytokine Levels |  | 8 weeks |