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

NCT03722511 | Completed Phase 2 DMC

• 1 other identifier: MCC-18-GI-101-EHS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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®.

Conditions

Neuroendocrine Tumors; Carcinoid Tumor of GI System; Diarrhea; Carcinoid Syndrome

Keywords

Enterade; Medical Food/Drink

Outcome Measures

Primary Outcomes (1)

• Effect of amino acids in tightening the intestinal barrier and protecting from antigenic translocation by evaluating plasma circulating cytokine levels in peripheral blood sample.

  ELISA assays will be used to assess pro-inflammatory cytokines IL-1β, IL-6 and TNFα and serum endotoxin from blood samples collected.

  56 days

Secondary Outcomes (1)

• Evaluation of increased bacterial translocation and systemic inflammation.

  56 days

Study Arms (2)

NET with carcinoid syndrome

ACTIVE COMPARATOR

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.

Dietary Supplement: Amino Acid Based Medical Food/Drink

NET w/o cardinoid syndrome

ACTIVE COMPARATOR

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.

Dietary Supplement: Amino Acid Based Medical Food/Drink

Interventions

Amino Acid Based Medical Food/Drink DIETARY_SUPPLEMENT

Study Compound Enterade® is a medical food drink/beverage composed of a proprietary blend of electrolytes and amino acids.

Also known as: Enterade®

NET w/o cardinoid syndrome; NET with carcinoid syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lowell Anthony, MD: lead
• Entrinsic Bioscience Inc.: collaborator

Study Sites (1)

University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Neuroendocrine Tumors; Diarrhea; Serotonin Syndrome

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Lowell Anthony

  Lucille P. Markey Cancer Center at University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 29, 2018
• Study Start: December 6, 2018
• Primary Completion: May 18, 2021
• Study Completion: May 18, 2021
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)