CompletedPhase 2

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

United States10 participantsStarted 2018-12-06

Plain-language 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®.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 req…

What they're measuring

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

Timeframe: 56 days

Trial details

NCT IDNCT03722511

SponsorLowell Anthony, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-18