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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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ClinicalTrials.gov Identifier: NCT03451253
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Entrinsic Health Solutions, 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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Short Bowel Syndrome Ileostomy - Stoma Other: amino acid mixture beverage Other: glucose-based sports drink Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 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.
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 : April 12, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Gatorade




Primary Outcome Measures :
  1. GI output [ Time Frame: 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 [ Time Frame: 8 weeks ]
    Fluid balance - intake vs output

  2. Tolerability of Drink [ Time Frame: 8 weeks ]
    Taste perception Survey

  3. Quality of Life [ Time Frame: 8 weeks ]
    Inflammatory Bowel Disease Questionnaire (IBDQ)

  4. Quality of Life [ Time Frame: 8 weeks ]
    SF-36 Questionnaire

  5. Changes in Blood [ Time Frame: 8 weeks ]
    mm Hg

  6. Changes in heart rate [ Time Frame: 8 weeks ]
    Beats per minute

  7. Changes in Lactulose-Mannitol Test [ Time Frame: 8 weeks ]
    The standard test for leaky gut syndrome

  8. Immune Response based on Cytokine Levels [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451253


Locations
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United States, Massachusetts
Brighan and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Fernanda Quevedo    617-732-5500    SFERNANDAQUEVEDO@BWH.HARVARD.EDU   
Principal Investigator: Joshua Korzenik, MD.         
United States, New Hampshire
Dartmouth-Hitchcock Recruiting
Nashua, New Hampshire, United States, 03062
Contact: Anna Haron    603-653-3667    Anna.M.Haron@hitchcock.org   
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Susan Jackson    919-843-9071    susan_jackson@med.unc.edu   
Contact: Emily English    919-843-9071    emily_english@med.unc.edu   
Sponsors and Collaborators
Entrinsic Health Solutions, Inc.

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Responsible Party: Entrinsic Health Solutions, Inc.
ClinicalTrials.gov Identifier: NCT03451253     History of Changes
Other Study ID Numbers: 2017P000097
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Short Bowel Syndrome
Inflammation
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Malabsorption Syndromes
Postoperative Complications