E. Coli Nissle in Oncology

NCT02706184 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-05-15

No results posted yet for this study

Summary

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

Interventions

DRUG

E. coli Nissle suspension

Patients receive E. coli Nissle suspension

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Ardeypharm GmbH

    collaborator INDUSTRY
  • University of Hohenheim

    lead OTHER

Principal Investigators

  • Stephan C. Bischoff, Prof. · ZKES GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02706184 on ClinicalTrials.gov