Clinical trial · Interventional
E. Coli Nissle in Oncology
Randomized, Placebo Controlled Phase III Trial of a Microbiological Concomitant Therapy/Prevention of Chemotherapeutical Induced Diarrhea (Caused by Inflammation and an Impaired Intestinal Barrier) With E. Coli Nissle 1917 (EcN)-Suspension in Patients With Gastric and Colorectal Cancer
- 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)
In patients with gastric or colorectal cancers, where a treatment with 5-Fluoruracil in combination with other chemotherapeutic remedies (FLO, FOLFOX, FOLFOX-Bev, FOLFIRI) is planned, it shall be investigated whether E. coli Nissle suspension has an effect on duration and intensity of chemotherapy induced diarrhea.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| E. coli Nissle suspension | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Patients receive E. coli Nissle suspension
- interventionNames
- Drug: E. coli Nissle suspension
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- Patients receive placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Common toxicity criteria for diarrhea Version 4.0
- timeFrame
- Baseline vs. week 12
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female adults * patients with gastric or colorectal cancer (stages III or IV), where a treatment with 5-Fluoruracil in combination with other chemotherapeutic remedies (FLO, FOLFOX, FOLFOX-Bev, FOLFIRI) is planned * life expectancy of at least the trial duration * the first administering of the product under investigation must be able to take place 72 hours before or after the beginning of the chemotherapeutical treatment, ideally at the same time * an inclusion into the study is only possible at the beginning of the first chemotherapeutic cycle * fertile female patients (aged 49 years or minor, the last menstruation occured in less than two years) have to be either surgically sterilized or use the same highly effective method of contraception for at least three months * willingness to refrain from other probiotics or probiotic yoghurts, a systematic change of eating behavior should not be planned * sufficient knowledge of german language and sufficient psychological state for being able to answer questionnaires and assessment scales * informed written consent Exclusion Criteria: * Participation in other clinical trials (currently or within the last 30 days) * intolerance against ingredients of the product under investigation * pregnancy or lactation * being not able to consume the product under investigation orally * antidiarrheal therapy with antibiotics * alcohol or drug abuse within the last six months * any health condition (including abnormal blood parameters) which refuses a patient from taking part in the study according to the opinion of the investigator
References
Publications (0)
Data not yet available