Back to resultsEffects of an Amino Acid Mixture on Gastrointestinal Function, Inflammation and Fluid Balance: A Pilot Study in Patients With Inflammatory Bowel Disease
Primary Purpose
Inflammatory Bowel Diseases, Short Bowel Syndrome, Ileostomy - Stoma
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
amino acid mixture beverage
glucose-based sports drink
Sponsored by
About this trial
This is an interventional other trial for Inflammatory Bowel Diseases
Eligibility Criteria
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
Sites / Locations
- Brighan and Women's Hospital
- Dartmouth-Hitchcock
- University of North Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
amino acid mixture beverage
glucose based sports drink
Arm Description
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 hydration beverage. It will be given 8oz, twice daily for the first 4 weeks of randomized blinded intervention.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Fluid Balance
Fluid balance - intake vs output
Tolerability of Drink
Taste perception Survey
Quality of Life Index
Inflammatory Bowel Disease Questionnaire (IBDQ)
Quality of Life Index
SF-36 Questionnaire
Changes in Blood
mm Hg
Changes in heart rate
Beats per minute
Changes in Lactulose-Mannitol Test
The standard test for leaky gut syndrome
Immune Response based on Cytokine Levels
Full Information
NCT ID
NCT03451253
First Posted
February 20, 2018
Last Updated
March 21, 2023
Sponsor
Entrinsic Bioscience Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03451253
Brief Title
Effects of an Amino Acid Mixture on Gastrointestinal Function, Inflammation and Fluid Balance: A Pilot Study in Patients With Inflammatory Bowel Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Suboptimal accrual
Study Start Date
April 12, 2018 (Actual)
Primary Completion Date
March 23, 2021 (Actual)
Study Completion Date
March 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Entrinsic Bioscience Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Short Bowel Syndrome, Ileostomy - Stoma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
4 week randomized into 2 arms, followed by 4 weeks of open label non-randomized follow-up.
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
Single (physician) blinded.
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
amino acid mixture beverage
Arm Type
Experimental
Arm Description
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.
Arm Title
glucose based sports drink
Arm Type
Active Comparator
Arm Description
glucose based hydration beverage. It will be given 8oz, twice daily for the first 4 weeks of randomized blinded intervention.
Intervention Type
Other
Intervention Name(s)
amino acid mixture beverage
Other Intervention Name(s)
enterade
Intervention Description
commercially available amino acid mixture. Contains 5 amino acids, electrolytes and natural flavoring.
Intervention Type
Other
Intervention Name(s)
glucose-based sports drink
Other Intervention Name(s)
Gatorade
Intervention Description
Commercially available glucose-based sports drink, contains electrolytes, sugar and artificial flavoring.
Primary Outcome Measure Information:
Title
GI output
Description
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
Time Frame
total 8 weeks
Secondary Outcome Measure Information:
Title
Fluid Balance
Description
Fluid balance - intake vs output
Time Frame
8 weeks
Title
Tolerability of Drink
Description
Taste perception Survey
Time Frame
8 weeks
Title
Quality of Life Index
Description
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame
8 weeks
Title
Quality of Life Index
Description
SF-36 Questionnaire
Time Frame
8 weeks
Title
Changes in Blood
Description
mm Hg
Time Frame
8 weeks
Title
Changes in heart rate
Description
Beats per minute
Time Frame
8 weeks
Title
Changes in Lactulose-Mannitol Test
Description
The standard test for leaky gut syndrome
Time Frame
8 weeks
Title
Immune Response based on Cytokine Levels
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Brighan and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dartmouth-Hitchcock
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03062
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of an Amino Acid Mixture on Gastrointestinal Function, Inflammation and Fluid Balance: A Pilot Study in Patients With Inflammatory Bowel Disease
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