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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-12

Study Completion Date

2021-03-23

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.

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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.

Conditions

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Inflammatory Bowel Diseases Short Bowel Syndrome Ileostomy - Stoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

4 week randomized into 2 arms, followed by 4 weeks of open label non-randomized follow-up.

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Single (physician) blinded.

Study Groups

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amino acid mixture beverage

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.

Group Type EXPERIMENTAL

amino acid mixture beverage

Intervention Type OTHER

commercially available amino acid mixture. Contains 5 amino acids, electrolytes and natural flavoring.

glucose based sports drink

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

Group Type ACTIVE_COMPARATOR

glucose-based sports drink

Intervention Type OTHER

Commercially available glucose-based sports drink, contains electrolytes, sugar and artificial flavoring.

Interventions

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amino acid mixture beverage

commercially available amino acid mixture. Contains 5 amino acids, electrolytes and natural flavoring.

Intervention Type OTHER

glucose-based sports drink

Commercially available glucose-based sports drink, contains electrolytes, sugar and artificial flavoring.

Intervention Type OTHER

Other Intervention Names

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enterade Gatorade

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No