Clinical trial · Interventional
Safety Assessment of Lactobacillus Fermented Extract in Cancer Patients Undergoing Chemotherapy
Assessment of the Safety of Dietary Supplement Lactobacillus Fermented Extract in Cancer Patients Undergoing Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): FDA sent letter to IRB stating it should be done under new drug application
Summary
Brief summary (as posted)
Project: Assessment of the safety of dietary supplement lactobacillus fermented extract in cancer patients undergoing chemotherapy Nausea and vomiting are significant causes of nutritional depletion and result in further deterioration of the physical and mental status. Support of gastrointestinal function may alleviate nausea and vomiting from chemotherapy and will not only reduce the discomfort experienced by the patient but will allow better tolerance of the treatment. This study will assess orally administered Seigen alpha EV during chemotherapy for its safety and effects on the nutritional depletion deriving from the chemotherapy. It will also look at its effect on the immune system in patients undergoing chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo Comparator | Dietary Supplement | — | UNRESOLVED |
| Seigen Alpha EV | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- Seigen Alpha EV Treatment
- interventionNames
- Dietary Supplement: Seigen Alpha EV
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- Identically packaged placebo packets taken 3x daily for 3 months maximum
- interventionNames
- Dietary Supplement: Placebo Comparator
Primary outcomes (1)
- measure
- Change in self-rated symptoms and assessed signs
- timeFrame
- 3 months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Eligible subjects have given written informed consent prior to participation * They must have a life expectancy of greater than 6 months * They must have biopsy confirmed primary breast, colon or lung cancer * They are receiving standard chemotherapy in accordance with American Society Clinical Oncology (ASCO) standards and have at least one month remaining in their chemotherapy course * They must have an Eastern Cooperative Oncology Group (ECOG) performance status \< 2 and are being treated as outpatients. * Subjects must be between the ages of 18 to 75 years of age. * Subjects must be able to communicate in English. Exclusion Criteria: * Have received radiotherapy within the last 4 weeks * Have acute gastrointestinal problems e.g. acute gastrointestinal infection, gastric or duodenal ulcer, history of bowel obstruction, diverticulitis, Crohn's disease, ulcerative colitis, or chronic diarrhea * Presence or clinical evidence of CNS metastases * Receiving corticosteroids * Have severe concomitant disease * Have severe dysphagia, esophagitis or xerostoma
References
Publications (0)
Data not yet available