Trial | NCT02706184  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
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.
Chemotherapy is used frequently for treating tumors. For many kinds of tumors, chemotherapy is an effective way of treatment. Besides the desired effects on neoplastic cells, the cytotoxic effects often lead to undesirable effects in other cells. Particularly the epithelial tissue of the gastrointestinal tract is affected, mucositis and diarrhea occur. By loss of water and electrolytes, diarrhea often make delay in chemotherapy necessary. Besides mucositis, a chemotherapy also causes changes in gut microbiota as animal models proof. It is well known, than probiotics shorten diarrhea. So far, the use of probiotics in chemotherapy patients was only investigated in one single study. Severity of diarrhea was reduced compared to placebo. Escherichia coli Nissle 1917 (EcN) is a well investigated probiotic. In cell culture, the supernatant of EcN reduced the noxious effect of 5-Fluoruracil concerning cell toxicity and disruption of barrier function.

Therefore, the aim of this study is whether 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, EcN-Suspension is capable to reduce duration and intensity of chemotherapy induced diarrhea.
Study Started
Jul 31
2015
Primary Completion
Jan 31
2018
Study Completion
Jan 31
2018
Last Update
May 15
2018

Drug E. coli Nissle suspension

Patients receive E. coli Nissle suspension

  • Other names: Mutaflor Suspension®

Drug Placebo

Placebo

Intervention Experimental

Patients receive E. coli Nissle suspension

Control Placebo Comparator

Patients receive placebo

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
No Results Posted