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

• Sponsor: Entrinsic Bioscience Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03451253
• Collaborator: (none)
• Enrollment: 7
• Locations: 3
• Arms: 2
• Actual Duration (Months): 35.4
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases; Short Bowel Syndrome; Ileostomy - Stoma	Other: amino acid mixture beverage; Other: glucose-based sports drink	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 4 week randomized into 2 arms, followed by 4 weeks of open label non-randomized follow-up.4 week randomized into 2 arms, followed by 4 weeks of open label non-randomized follow-up.
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Single (physician) blinded.
• Primary Purpose: Other
• Official Title: 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
• Actual Study Start Date: Apr 12, 2018
• Actual Primary Completion Date: Mar 23, 2021
• Actual Study Completion Date: Mar 23, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Fluid Balance [8 weeks]

   Fluid balance - intake vs output

2. Tolerability of Drink [8 weeks]

   Taste perception Survey

3. Quality of Life [8 weeks]

   Inflammatory Bowel Disease Questionnaire (IBDQ)

4. Quality of Life [8 weeks]

   SF-36 Questionnaire

5. Changes in Blood [8 weeks]

   mm Hg

6. Changes in heart rate [8 weeks]

   Beats per minute

7. Changes in Lactulose-Mannitol Test [8 weeks]

   The standard test for leaky gut syndrome

8. Immune Response based on Cytokine Levels [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Colectomy with ileostomy

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

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

2. Any of the following:

3. Need for IV fluids >2x/month

4. Intake of > 1.5 liters of oral fluid daily

5. 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)

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

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

8. 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

1. (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

1. Diabetes

2. Use of Lactulose/Mannitol solution is contraindicated

3. Current Diagnosis of Cancer

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brighan and Women's Hospital	Boston	Massachusetts	United States	02115
2	Dartmouth-Hitchcock	Nashua	New Hampshire	United States	03062
3	University of North Carolina	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

• Entrinsic Bioscience Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Entrinsic Bioscience Inc.
• ClinicalTrials.gov Identifier: NCT03451253
• Other Study ID Numbers: 2017P000097
• First Posted: Mar 1, 2018
• Last Update Posted: Mar 25, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases; Short Bowel Syndrome; Inflammation

Study Results

No Results Posted as of Mar 25, 2021