Overview

E. Coli Nissle in Oncology

Status:
Completed
Trial end date:
2018-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Hohenheim
Collaborator:
Ardeypharm GmbH
Criteria
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