Clinical trial · Interventional
Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency
Proprietary Amino Acid-Based Medical Food (Enterade) in Carcinoid Syndrome and Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency
NCT04073017CI-TRIAL-00051933terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
This is an open-label phase II basket study evaluating the ability of enterade® to reduce bowel frequency in neuroendocrine tumor (NET) patients with carcinoid syndrome and non-carcinoid syndrome.
Conditions
Conditions (2)
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 | — |
| Neuroendocrine Tumor | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enterade® | Dietary Supplement | — | UNRESOLVED |
| Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Enterade
- description
- Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks.
- interventionNames
- Dietary Supplement: Enterade®
- Other: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Non-Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks.
- interventionNames
- Dietary Supplement: Enterade®
- Other: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Carcinoid syndrome: Participants must have histopathologically confirmed neuroendocrine tumor with 4 or more bowel movements per day on standard anti-diarrheal regimen (which includes somatostatin analogs and/or Telotristat Ethyl). Additionally, a plasma 5-HIAA, or a urine 24-hour 5-HIAA or plasma secretory hormone levels (VIP, gastrin) above the upper limit of normal per reference lab. Patients may be grouped into this cohort based on a previous plasma 5-HIAA level though the final cohort determination will be made based upon the 5-HIAA level drawn during screening. Non-Carcinoid Syndrome: 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), but do not have elevated results for one of the following: plasma 5-HIAA, or 24-hour urine 5-HIAA or other plasma secretory hormone levels (VIP, gastrin) above the upper limit of normal per reference lab. Patients may be grouped into this cohort based on a previous plasma 5-HIAA level though the final cohort determination will be made based upon the 5-HIAA level drawn during screening * 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 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 3 months. * Pregnant or breastfeeding women. The safety of enterade® has not been validated in this patient population.
References
Publications (0)
Data not yet available
No reference posted for this study.