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

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

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 Overview

• Status: Terminated
• Conditions: Inflammatory Bowel Diseases; Ileostomy - Stoma; Short Bowel Syndrome
• Intervention / Treatment: Other: amino acid mixture beverage; Other: glucose-based sports drink

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brighan and Women's Hospital
  • New Hampshire
    • Nashua, New Hampshire, United States, 03062
      • Dartmouth-Hitchcock
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: amino acid mixture beverage; commercially available amino acid mixture. Contains 5 amino acids, electrolytes and natural flavoring.; Other Names: enterade
Active Comparator: glucose based sports drink; 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; Commercially available glucose-based sports drink, contains electrolytes, sugar and artificial flavoring.; Other Names: Gatorade

What is the study measuring?

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
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
Quality of Life Index	Inflammatory Bowel Disease Questionnaire (IBDQ)	8 weeks
Quality of Life Index	SF-36 Questionnaire	8 weeks

Collaborators and Investigators

• Sponsor: Entrinsic Bioscience Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2018
• Primary Completion (Actual): March 23, 2021
• Study Completion (Actual): March 23, 2021

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: February 23, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Gastrointestinal Diseases; Gastroenteritis; Malabsorption Syndromes; Inflammation; Inflammatory Bowel Diseases; Intestinal Diseases; Short Bowel Syndrome
• Other Study ID Numbers: 2017P000097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No