E. Coli Nissle in Oncology (EcNO)

University of Hohenheim

Status and phase

Completed

Phase 3

Conditions

Gastric Cancer

Colorectal Cancer

Treatments

Drug: Placebo

Drug: E. coli Nissle suspension

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02706184

ZKES-EcNO-2015

Details and patient eligibility

About

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.

Full description

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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