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

NCT03722511 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-11-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Entrinsic Bioscience Inc.

    collaborator INDUSTRY

  • Lowell Anthony, MD

    lead OTHER

Principal Investigators

  • Lowell Anthony · Lucille P. Markey Cancer Center at University of Kentucky

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-06
Primary Completion
2021-05-18
Completion
2021-05-18

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03722511 on ClinicalTrials.gov