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

Not Applicable

Terminated

• Conditions: Inflammatory Bowel Diseases; Short Bowel Syndrome; Ileostomy - Stoma
• Interventions: Other: amino acid mixture beverage; Other: glucose-based sports drink

• Registration Number: NCT03451253
• Lead Sponsor: Entrinsic Bioscience Inc.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-02-23
• Study First Posted: 2018-03-01
• Study Start: 2018-04-12
• Primary Completion: 2021-03-23
• Study Completion: 2021-03-23
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
amino acid mixture beverage	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.
glucose based sports drink	glucose-based sports drink	glucose based hydration beverage. It will be given 8oz, twice daily for the first 4 weeks of randomized blinded intervention.

Primary Outcome Measures

Name	Time	Method
GI output	total 8 weeks	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

Secondary Outcome Measures

Name	Time	Method
Changes in Blood	8 weeks	mm Hg
Changes in Lactulose-Mannitol Test	8 weeks	The standard test for leaky gut syndrome
Tolerability of Drink	8 weeks	Taste perception Survey
Quality of Life Index	8 weeks	SF-36 Questionnaire
Changes in heart rate	8 weeks	Beats per minute
Immune Response based on Cytokine Levels	8 weeks
Fluid Balance	8 weeks	Fluid balance - intake vs output

Trial Locations

Locations (3)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Brighan and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Dartmouth-Hitchcock; 🇺🇸 Nashua, New Hampshire, United States