E. Coli Nissle in Oncology

University of Hohenheim20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Gastric Cancer Colorectal Cancer

Interventions

E. coli Nissle suspensionDRUG

Patients receive E. coli Nissle suspension

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Klinikum Ludwigsburg

Ludwigsburg, Baden-Wurttemberg, Germany

Paracelsus-Krankenhaus Ruit

Ostfildern, Baden-Wurttemberg, Germany

Klinikum am Steinenberg /Ermstalklinik

Reutlingen, Baden-Wurttemberg, Germany

Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, Germany