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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE February 20, 2018
First Posted Date  ICMJE March 1, 2018
Last Update Posted Date June 3, 2019
Actual Study Start Date  ICMJE April 12, 2018
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03451253 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2018)
  • Fluid Balance [ Time Frame: 8 weeks ]
    Fluid balance - intake vs output
  • Tolerability of Drink [ Time Frame: 8 weeks ]
    Taste perception Survey
  • Quality of Life [ Time Frame: 8 weeks ]
    Inflammatory Bowel Disease Questionnaire (IBDQ)
  • Quality of Life [ Time Frame: 8 weeks ]
    SF-36 Questionnaire
  • Changes in Blood [ Time Frame: 8 weeks ]
    mm Hg
  • Changes in heart rate [ Time Frame: 8 weeks ]
    Beats per minute
  • Changes in Lactulose-Mannitol Test [ Time Frame: 8 weeks ]
    The standard test for leaky gut syndrome
  • Immune Response based on Cytokine Levels [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of an Amino Acid Mixture on Gastrointestinal Function, Inflammation and Fluid Balance: A Pilot Study in Patients With Inflammatory Bowel Disease
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Inflammatory Bowel Diseases
  • Short Bowel Syndrome
  • Ileostomy - Stoma
Intervention  ICMJE
  • Other: amino acid mixture beverage
    commercially available amino acid mixture. Contains 5 amino acids, electrolytes and natural flavoring.
    Other Name: enterade
  • Other: glucose-based sports drink
    Commercially available glucose-based sports drink, contains electrolytes, sugar and artificial flavoring.
    Other Name: Gatorade
Study Arms  ICMJE
  • 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.
    Intervention: Other: amino acid mixture beverage
  • 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.
    Intervention: Other: glucose-based sports drink
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 23, 2018)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03451253
Other Study ID Numbers  ICMJE 2017P000097
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Entrinsic Health Solutions, Inc.
Study Sponsor  ICMJE Entrinsic Health Solutions, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Entrinsic Health Solutions, Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP