Clinical trial · Interventional
Evaluating an Amino Acid Based Medical Food w/ Diarrhea in Carcinoid Syndrome & Other NETs
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).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoid Syndrome | — | UNRESOLVED | — |
| Carcinoid Tumor of GI System | Digestive System Neuroendocrine Tumor G1 | ALIAS | 0.90 |
| Diarrhea | — | UNRESOLVED | — |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amino Acid Based Medical Food/Drink | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- NET with carcinoid syndrome
- description
- 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.
- interventionNames
- Dietary Supplement: Amino Acid Based Medical Food/Drink
- type
- ACTIVE_COMPARATOR
- label
- NET w/o cardinoid syndrome
- description
- 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.
- interventionNames
- Dietary Supplement: Amino Acid Based Medical Food/Drink
Primary outcomes (1)
- measure
- Effect of amino acids in tightening the intestinal barrier and protecting from antigenic translocation by evaluating plasma circulating cytokine levels in peripheral blood sample.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available