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Evaluating an Amino Acid Based Medical Food w/ Diarrhea in Carcinoid Syndrome & Other NETs

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ClinicalTrials.gov Identifier: NCT03722511
Recruitment Status : Recruiting
First Posted : October 29, 2018
Last Update Posted : February 21, 2020
Sponsor:
Collaborator:
Entrinsic Health Solutions, Inc.
Information provided by (Responsible Party):
Lowell Anthony, MD, University of Kentucky

Tracking Information
First Submitted Date  ICMJE October 25, 2018
First Posted Date  ICMJE October 29, 2018
Last Update Posted Date February 21, 2020
Actual Study Start Date  ICMJE December 6, 2018
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
Effect of amino acids in tightening the intestinal barrier and protecting from antigenic translocation by evaluating plasma circulating cytokine levels in peripheral blood sample. [ Time Frame: 56 days ]
ELISA assays will be used to assess pro-inflammatory cytokines IL-1β, IL-6 and TNFα and serum endotoxin from blood samples collected.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
Evaluation of increased bacterial translocation and systemic inflammation. [ Time Frame: 56 days ]
Gut inflammation will be assessed through the analysis of fecal lactoferrin using stool specimens.
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 Evaluating an Amino Acid Based Medical Food w/ Diarrhea in Carcinoid Syndrome & Other NETs
Official Title  ICMJE A Phase 2 Study Evaluating a Proprietary Amino Acid Based Medical Food (Enterade®) in Patients With Quality of Life Limiting Diarrhea Due to Carcinoid Syndrome and Other Neuroendocrine Tumors (NET).
Brief Summary

Primary Objective:

To assess how an amino acid based medical food (Enterade®) helps maintain the intestine's ability to absorb and retain fluids, leading to a reduction in diarrhea due to Neuroendocrine Tumors (NET) and/or Carcinoid Syndrome. This improvement in the absorption will be assessed in part by evaluating changes in average daily stool frequency from baseline in patients receiving Enterade®. Each subject serves as his or her own control.

Secondary Objectives:

  • To assess subject reported health-related quality of life in subjects before and after compound administration.
  • To characterize the side effect profile and tolerability of Enterade® as measured by the number of total 8-oz Enterade® bottles consumed throughout the trial, and average drinks per day.
  • To evaluate changes in serum electrolytes before and after administration of Eenterade®.
  • To assess intravenous fluid requirement and/or hospitalization for dehydration secondary to diarrhea between control observation period and active Enterade® period.
  • To evaluate difference in utilization of standard-of-care anti-diarrheal medications between control observation period and Enterade® period.
  • To compare subjective feeling of bloating and flatulence before and after administration of Enterade®.
  • To evaluate changes in patient weight before and after administration of Enterade®.
Detailed Description

This prospective, phase 2 study is to assess how Enterade® will affect patient-reported quality of life and intestinal absorption in patients with Carcinoid Syndrome and Neuroendocrine Tumors. The hypothesis is that Enterade® when combined with standard supportive care will improve patient-reported quality of life and help maintain the small bowel's ability to absorb and retain fluids, possibly leading to a reduction in diarrhea frequency.

  • This is a non-randomized, supportive-care study.
  • Potentially eligible patients will be screened in the University of Kentucky Markey Cancer Center clinics.
  • During the screening visit, immediately after signing informed consent, the participant will be given both flavors of enterade® (original vanilla and refreshing orange) to test tolerability and taste.
  • Eligible subjects will be given a stool diary and will be asked to document daily stool output (frequency and consistency of stool), use of anti-diarrheal medication and gastrointestinal discomforts (bloating, cramping).
  • All lab and screening tests should be completed within 2 weeks prior to registration/initiation of study.
  • The study is broken into 3 distinct segments and will apply to all enrolled participants: Baseline observation (Weeks 1-4), Enterade® administration period (4 weeks), Post-Enterade® Period (4 weeks).
  • After relapse of diarrhea is documented or the 4 weeks of post-Enterade® observation are completed (whatever happens first), participants will be given the option to restart Enterade® for 1 additional month.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Neuroendocrine Tumors
  • Carcinoid Tumor of GI System
  • Diarrhea
  • Carcinoid Syndrome
Intervention  ICMJE Dietary Supplement: Amino Acid Based Medical Food/Drink
Study Compound Enterade® is a medical food drink/beverage composed of a proprietary blend of electrolytes and amino acids.
Other Name: Enterade®
Study Arms  ICMJE
  • Active Comparator: NET with carcinoid syndrome
    Participants with NET and carcinoid syndrome will be instructed to drink two 8 oz. bottles of Amino Acid Based Medical Food/Drink (Enterade®) per day.
    Intervention: Dietary Supplement: Amino Acid Based Medical Food/Drink
  • Active Comparator: NET w/o cardinoid syndrome
    Participants with NET w/o carcinoid syndrome will be instructed to drink two 8 oz. bottles of Amino Acid Based Medical Food/Drink (Enterade®) per day.
    Intervention: Dietary Supplement: Amino Acid Based Medical Food/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: October 25, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2030
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Cohort 1: Participants must have histopathologically confirmed neuroendocrine tumor with 4 or more bowel movements per day on standard anti-diarrheal regimen (which may or may not include somatostatin analogs and telotristat), AND an elevated serum serotonin or plasma serotonin above the upper limit of normal per reference lab.
  • Cohort 2: Participants who have histopathologically confirmed neuroendocrine tumor and have 4 or more bowel movements per day on standard anti-diarrheal regimen (which may or may not include somatostatin analogs and telotristat), but are below the cut-point for serotonin elevation.
  • Age equal to or greater than 18 years old.
  • ECOG performance status ≤2 (Karnofsky ≥60%)
  • Ability to tolerate thin liquids by mouth at the time of enrollment.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Subject who are willing to take enterade® as instructed will be eligible.

Exclusion Criteria:

  • Known allergy to Stevia.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active Clostridium difficile infection or history of Clostridium difficile infection.
  • Participants with active clostridium difficile infection will be ineligible for this study.
  • Participants with a history of inflammatory bowel disease, irritable bowel syndrome, bariatric surgery and/or Celiac disease.
  • Participants with psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients who have had enterade® within the past 12 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cynthia Leedham, PhD 859-257-4470 cleed2@email.uky.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03722511
Other Study ID Numbers  ICMJE MCC-18-GI-101-EHS
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 Lowell Anthony, MD, University of Kentucky
Study Sponsor  ICMJE Lowell Anthony, MD
Collaborators  ICMJE Entrinsic Health Solutions, Inc.
Investigators  ICMJE
Principal Investigator: Lowell Anthony Lucille P. Markey Cancer Center at University of Kentucky
PRS Account University of Kentucky
Verification Date February 2020

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